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ENT OF D

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Department of Defense
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IT I
ED
S MER
TATES OF A

Report on Search
for
Human Radiation Experiment
Records

1944 — 1994
Volume 1

Assistant to the Secretary of Defense for


Nuclear and Chemical and Biological Defense Programs
This report has been reproduced directly from the best available copy.

Available to the public from


the U.S. Department of Commerce,
Technology Administration,
National Technical Information Service,
Springfield, VA 22161
Department of Defense

Report on Search
for Human Radiation
Experiment Records

1944 - 1994
Volume 1

Assistant to the Secretary of Defense for


Nuclear and Chemical and Biological
Defense Programs

June 1997
ii
TABLE OF CONTENTS
FIGURES AND TABLES .................................................................................................................. vii

FOREWORD BY THE SECRETARY OF DEFENSE .................................................................................... i x

INTRODUCTION ............................................................................................................................. x i

CHAPTER 1—DOD HUMAN SUBJECTS PROTECTION POLICY 1944 TO THE PRESENT ............................... 1
Introduction ...................................................................................................................................... 1
Evolution of DoD Human Subjects Protection Policy ...................................................................... 1
The Wilson Memorandum .............................................................................................................. 13
Dissemination and Implementation of the Wilson Memorandum .................................................. 13
Evolution of Policies and Regulations............................................................................................ 15
Current DoD Policy for Human Subjects Protection ...................................................................... 16
Clinical Investigations Programs .................................................................................................... 16
Biomedical Research and Development Programs ....................................................................... 17

CHAPTER 2—TOTAL-BODY & PARTIAL-BODY IRRADIATION STUDIES ................................................... 23


Total-Body Irradiation Treatment for Cancer .................................................................................. 23
Department of Defense Interest in Total-Body Irradiation Research ............................................ 23
“Systematic and Clinical Effects of Whole-Body X-Irradiation” ...................................................... 24
The University of Texas MD Anderson Hospital and Tumor Clinic of Houston .............................. 24
Background of Total Body Irradiation Research at MD Anderson Hospital ............................. 24
Research Goals ....................................................................................................................... 25
Patients and Treatments .......................................................................................................... 26
Exposure to Total-Body Irradiation ........................................................................................... 26
Psychomotor Tests ................................................................................................................... 26
Research Results ..................................................................................................................... 27
“The Effects of TBI and PBI on Iron Metabolism and Hematopoiesis” .......................................... 28
Baylor University College of Medicine, Houston, Texas ................................................................ 28
Background of Total Body Irradiation Research at Baylor University College of Medicine ..... 28
Research Goals ....................................................................................................................... 28
Patients and Treatment ............................................................................................................ 28
Research Results ..................................................................................................................... 29
“The Study of the Post-Irradiation Syndrome in Humans” ............................................................. 29
Sloan-Kettering Institute for Cancer Research .............................................................................. 29
Background of Total-Body Irradiation Research at Sloan-Kettering Institute for
Cancer Research .................................................................................................................. 29
Patients and Treatment ............................................................................................................ 30
Research Results ..................................................................................................................... 30
“Radiation Effects in Man: Manifestations and Therapeutic Efforts” ............................................ 30

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iv DOD REPORT ON SEARCH FOR HUMAN RADIATION EXPERIMENT RECORDS 1944-1994

University of Cincinnati College of Medicine ................................................................................. 30


Background of Total-Body Irradiation Research at the University of Cincinnati College of
Medicine ................................................................................................................................ 30
Patients and Treatments .......................................................................................................... 31
Research Results ..................................................................................................................... 31
Psychological Studies .............................................................................................................. 31
UCCM Review Processes ........................................................................................................ 32
“Use of Total-Body Radiation in the Treatment of Far-Advanced Malignancies” ........................... 32
U.S. Naval Hospital, National Naval Medical Center, Bethesda, Maryland ................................... 32
Background of Total Body Irradiation Research at the U.S. Naval Hospital, Bethesda,
Maryland ............................................................................................................................... 32
Patients and Treatment ............................................................................................................ 33
Research Results ..................................................................................................................... 33
Summary ........................................................................................................................................ 33

CHAPTER 3—NASOPHARYNGEAL IRRADIATION THERAPY .................................................................... 37


Background and Overview ............................................................................................................. 37
The Development of Radium Rod Treatment ................................................................................ 37
Civilian Research and Implementation .......................................................................................... 37
Military Uses of Radium Rod Treatment ........................................................................................ 38
Aircrew Radium Treatment ............................................................................................................ 38
Submariner Radium Treatment ...................................................................................................... 39
Discontinuation of Radium Rod Therapy ....................................................................................... 40
Retrospective Studies .................................................................................................................... 40
Current Focus on Nasopharyngeal Therapy .................................................................................. 41
Summary ........................................................................................................................................ 42

CHAPTER 4—IODINE-131 STUDY CONDUCTED BY THE ARCTIC AEROMEDICAL LABORATORY ................... 45


Introduction .................................................................................................................................... 45
Background .................................................................................................................................... 45
“Thyroid Activity in Men Exposed to Cold” ..................................................................................... 45
Summary ........................................................................................................................................ 47

CHAPTER 5—INTENTIONAL ATMOSPHERIC RELEASES OF RADIOACTIVE MATERIAL ................................. 49


Green Run ...................................................................................................................................... 49
The Hanford Site ...................................................................................................................... 49
What Was Green Run? ............................................................................................................ 49
Preparations for Green Run ..................................................................................................... 51
The Green Run Event .............................................................................................................. 51
Measuring Contamination ........................................................................................................ 53
Access to Further Information on Green Run .......................................................................... 54
The RaLa Program ........................................................................................................................ 54
The Los Alamos Scientific Laboratory Site .............................................................................. 54
The RaLa Studies .................................................................................................................... 54
Access to Further Information on RaLa ................................................................................... 56
DOD REPORT ON SEARCH FOR HUMAN RADIATION EXPERIMENT RECORDS 1944-1994 v

CHAPTER 6—RADIOLOGICAL WARFARE ......................................................................................... 59


Introduction .................................................................................................................................... 59
Reconsideration of Radiological Warfare ...................................................................................... 59
The Joint Radiological Warfare Study Panel ................................................................................. 60
The Army Chemical Corps Test Safety Panel ................................................................................ 61
Radiological Agent Selection ......................................................................................................... 61
The Test Programs ......................................................................................................................... 61
Oak Ridge Tests ....................................................................................................................... 61
Dugway Tests ........................................................................................................................... 62
Munition Tests .......................................................................................................................... 63
Decontamination and Construction Studies ............................................................................. 66
The Joint Radiological Warfare Study Panel Reevaluation ........................................................... 67
The Cancellation of the Offensive Radiological Warfare Program ................................................ 67
Summary ........................................................................................................................................ 67

CHAPTER 7—HUMAN ASPECTS RESEARCH & U.S. ATMOSPHERIC NUCLEAR WEAPONS TESTING ............ 71
Introduction .................................................................................................................................... 71
Background .................................................................................................................................... 71
Human Involvement ....................................................................................................................... 71
Development of Military Operations on a Nuclear Battlefield ......................................................... 71
Visual Effects ........................................................................................................................... 72
Nuclear Cloud Penetration Studies .......................................................................................... 74
Epilogue ......................................................................................................................................... 76
For More Information ..................................................................................................................... 76

CHAPTER 8—FOOD IRRADIATION .................................................................................................. 79


Introduction to Irradiated Food Studies.......................................................................................... 79
Background .................................................................................................................................... 79
Human Testing of Irradiated Foods ................................................................................................ 80
Follow-Up Studies .......................................................................................................................... 81
Summary ........................................................................................................................................ 84

APPENDIX 1—RESULTS OF DOD HUMAN RADIATION EXPERIMENT RECORDS SEARCH ........................... 87


What Information Is Displayed ....................................................................................................... 88
1944 - 1974 .................................................................................................................................... 88
1975 - 1994 .................................................................................................................................... 88
How to Find a Specific Project ....................................................................................................... 89

APPENDIX 2—INFORMATION SOURCES ......................................................................................... 477

APPENDIX 3—ACRONYMS & ABBREVIATIONS ................................................................................ 567

APPENDIX 4—RADIATION TERMS ................................................................................................ 571


vi
FIGURES & T ABLES
Page #
CHAPTER 1 HUMAN USE SUBJECTS PROTECTION POLICY
Terms Used in This Chapter .......................................................................................................... 1
Acronyms Used in This Chapter .................................................................................................... 2
Figure 1—DoD Organizations Involved in the Development of the Wilson Memorandum............ 3
Figure 2—The Wilson Memorandum ............................................................................................. 4
Figure 3—Wilson Memorandum Typeset from Original for Legibility ............................................ 7
The Nuremberg Code .................................................................................................................. 12
The Nuremberg Trials .................................................................................................................. 13

CHAPTER 2 TOTAL-BODY AND PARTIAL-BODY IRRADIATION


Table 1—Chronological Listing of Total-Body Irradiation/Partial-Body Irradiation Studies
Discussed in this Chapter ....................................................................................................... 24
Terms Used in This Chapter ........................................................................................................ 25
Table 2—Exposure to TBI as a Treatment for Cancer, MD Anderson ......................................... 26
Acronyms Used in This Chapter .................................................................................................. 27
Table 3—Scientific and Ethical Reviews of the UCCM Project ................................................... 32

CHAPTER 3 NASOPHARYNGEAL IRRADIATION THERAPY


Figure 1—Profile of the Nasopharynx Radium Applicator ........................................................... 38
Figure 2—Profile of a Human Skull Depicting the Emplacement of a Radium Applicator
for the Nasopharyngeal Irradiation Procedure ....................................................................... 38
Terms/Acronyms Used in This Chapter ....................................................................................... 39

CHAPTER 4 IODINE-131 STUDY CONDUCTED BY THE ARCTIC AEROMEDICAL LABORATORY


Terms/Acronyms Used in This Chapter ....................................................................................... 46

CHAPTER 5 INTENTIONAL ATMOSPHERIC RELEASES OF RADIOACTIVE MATERIAL


Map 1—The Hanford Engineer Works ......................................................................................... 50
Acronyms Used in This Chapter .................................................................................................. 51
Terms Used in This Chapter ........................................................................................................ 52
Figure 1—Hanford’s “T” plant, from where the Green Run Material was Released .................... 53
Map 2—Los Alamos Site .............................................................................................................. 55

CHAPTER 6 RADIOLOGICAL WARFARE


Acronyms Used in This Chapter .................................................................................................. 59
Terms Used in This Chapter ........................................................................................................ 60
Radiological Warfare Weapons Test Target Area at Dugway Proving Ground, Utah .................. 62
Table 1—Radiological Warfare Munition Tests Conducted at Dugway Proving Ground,
Utah, 1949-1952 .................................................................................................................... 64
Table 2—Radiological Warfare Decontamination and Construction Evaluation Field Tests
Conducted at Dugway Proving Ground, Utah, 1950-1952 .................................................... 66
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viii DOD REPORT ON SEARCH FOR HUMAN RADIATION EXPERIMENT RECORDS 1944-1994

CHAPTER 7 HUMAN ASPECTS RESEARCH & U.S. ATMOSPHERIC NUCLEAR WEAPONS TESTING
Terms/Acronyms Used in This Chapter ....................................................................................... 72
Photograph—Intensity of the flash of the detonation of an atomic bomb at night. The
intensity of the flash could cause temporary blindness to those unprotected ....................... 73
Photograph—“Box” filter being removed from a B-17 “drone” cloud sampling aircraft ............... 74
Photograph—Cloud sampling filter being placed on a cart after being removed from a F-84
sampling aircraft ..................................................................................................................... 75
Photograph—Air Force F-84 being directed to a holding area to await decontamination.
The aircraft had been on a cloud sampling mission. Upon landing, the aircraft was
surveyed for radioactivity and found to exceed acceptable levels. ....................................... 76
Photograph—Air Force F-84 undergoing decontamination after flying through an atomic
mushroom cloud ..................................................................................................................... 77

CHAPTER 8 FOOD IRRADIATION


Terms/Acronyms Used in This Chapter ....................................................................................... 80
Photograph—Potatoes being irradiated during a food preservation study. This process
did not cause the food itself to become radioactive. Rather, it destroyed organisms
which would have caused spoilage of the food. This process lengthened the storage
life of these foods. .................................................................................................................. 81
Photograph—Food test samples depicting effectiveness of irradiation as a preservation
process. Food on the right had been irradiated, whereas the food on the left had not.
Both samples had been left unprotected for the same period of time. Food on the left
shows signs of spoilage, whereas the food on the right does not. Food items are
sausage, bread, cheese, and beans. ..................................................................................... 82
Sterilization versus Pasteurization ............................................................................................... 83

APPENDIX 1 RESULTS OF DOD HUMAN RADIATION EXPERIMENT RECORDS SEARCH


Acronyms and Definitions Used in This Chapter ......................................................................... 88
F OREWORD

On behalf of the Department of Defense, I am pleased to present to the American people


this report on our search for information on the Department’s participation in human radiation
experiments, beginning with the dawn of the Atomic Age in 1944. Our effort was in support of
an intensive, Government-wide search for all relevant records directed by President Clinton in
January 1994, as part of the administration’s initiative for openness in government. Within the
Department of Defense, the effort involved hundreds of people throughout the Military Services
and Defense Agencies. In this regard, I recognize the tremendous effort required in a search of
this magnitude and want to thank them for their dedicated work.
Within this report, the reader will find four basic types of information: first, guidance for the
search issued by the President and more detailed instructions issued by other officials; second,
extensive summaries of several projects which either were “human radiation experiments” or for
other reasons have attracted wide public attention; third, brief descriptions of the more than
2,000 projects initially identified in the records search as having some connection between
humans and radiation; and finally, references for obtaining additional information.
Of note, although most of the above projects actually involved common and routine medical
practices, in the spirit of openness, all are included in this report. Further, in cases where we
have not been able to reconstruct full information from the old records, this fact is so noted with
an explanation that more data will be provided in a subsequent report.
I believe this report will answer many of the questions which the American people may still
have about human radiation experiments, and I invite them to let us know of any more
information that we might be able to provide.

ix
x
I NTRODUCTION
B ACKGROUND I NFORMATION 2. There had to be involvement of ionizing
“radiation.”
The intent of this publication is to inform the 3. There had to be an “experimental” element.
public about the Department of Defense (DoD)
involvement in ionizing radiation experiments, In this regard, we are aware that many of the 2,600
studies or projects with human subjects which studies initially reported by the DoD to the ACHRE
occurred from 1944 to 1994. This information is part did not meet the established criteria. However, to
of DoD’s extensive effort in support of President ensure a full accounting, the entire range of
William J. Clinton’s openness in government experiments/studies/projects was forwarded to the
initiatives that began in January 1994. In the spirit ACHRE for review and analysis. Such reporting was
of openness, this book includes a wide range of consistent with DoD’s guidance which required
records retrieved by the DoD. researchers to err on the side of inclusion during the
Defining human radiation experiments (HRE) is records search when there was insufficient
essential if the reader is to understand the “what” and information to determine whether or not the studies
the “why” regarding the contents of this publication. were human radiation experiments within the scope
To focus this effort, Executive Order (EO) 12891, of the definition. Of the 2,600 studies forwarded to
signed by President Clinton on 15 January 1994, the ACHRE, 2,389 are listed in this book and
established the Presidential Advisory Committee on provided without judgment. The difference between
Human Radiation Experiments (ACHRE) and the two totals is due to analysis conducted by the
provided the definition used by the DoD and other DoD after forwarding of the studies to the ACHRE
Federal departments and agencies in identifying that identified some studies as being duplicate
HRE. reporting, some that were not implemented, and
EO 12891 defined Human Radiation others which were found not to involve humans. The
Experiments as: results of this refined DoD records search for
experiments or studies are included in appendix 1.
1. Experiments on individuals involving inten- In some of the 1944 - 1974 projects, the RECC
tional exposure to ionizing radiation. This cat- was unable to compile a complete description. In
egory does not include common and routine these instances, a notation has been made in the
clinical practices, such as established diag- project entry that if this information becomes
nosis and treatment methods involving inci- available, it will be provided in volume 2 to this
dental exposures to ionizing radiation.
publication.
2. Experiments involving intentional environ-
In setting the scope, EO 12891 also identified
mental releases of radiation that were de- certain events that required specific attention by the
signed to test human health effects to ionizing ACHRE. They are the “Green Run” release at the
radiation, or were designed to test the extent Hanford Reservation, the six radiation warfare tests
of human exposure to ionizing radiation. conducted at Dugway Proving Ground in Utah, and
four atmospheric radiation tracking tests conducted
When reading this book, it is essential to in 1950 near Los Alamos, New Mexico. These are
remember the three components of an HRE: addressed in this book along with information about
both HRE and non-HRE events involving ionizing
1. There had to be “human” participation. radiation that have stirred public interest. These are

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xii DOD REPORT ON SEARCH FOR HUMAN RADIATION EXPERIMENT RECORDS 1944-1994

total body irradiation studies, nasopharyngeal was least known were the long-term effects of a less-
irradiation, cold weather tests involving radioactive than-immediately lethal exposure. The body of
iodine-131, human aspects research involving U.S. knowledge about these effects was woefully deficient
nuclear weapons tests, and food irradiation studies. as the United States began preparing for a possible
Appendices 2 through 4 provide additional reference nuclear conflict. The need to expand the body of
information. knowledge about this phenomenon was pressing, and
initiatives were undertaken to meet the need. The
newly formed DoD, along with other agencies, began
HISTORICAL OVERVIEW OF 1944 - 1974 AND research into the effects of ionizing radiation.
WHAT L ED TO HUMAN R ADIATION E XPERIMENTS Ionizing radiation effects were not completely
new to science. Ionizing radiation had been used in
In the years following World War II, a period of both industrial and medical procedures before World
intense confrontation evolved between the War II. As the nuclear age began, the benefits and
communist and democratic governments of the hazards of exposure to ionizing radiation were just
world. Many former allies became fierce opponents in being realized. Although it could be deadly in certain
an era that became known as the Cold War. The two instances, ionizing radiation also showed great
principal powers—the United States and the Soviet promise in treating serious illnesses and analyzing
Union—came to be symbolically identified as metals and substances.
superpowers advocating opposing ideologies. The X-ray machines emitting ionizing radiation
military establishments in each camp heightened enabled doctors to “see” illnesses or injuries in the
their preparations for what many expected to become body whose diagnosis previously required exploratory
an eventual state of open warfare. surgery or educated guesses. In industrial uses, x-ray
Into this already highly charged environment machines permitted viewing the insides of welds and
came the threat of nuclear warfare. The United metals to identify defects. Many lives would be saved
States developed the first atomic bombs during World by detecting such deficiencies.
War II and used them against Japan. The war ended However, in many of the early applications of
soon after the United States dropped the bombs on ionizing radiation, it soon became clear that more
Hiroshima and Nagasaki. The United States’ knowledge about the effects of long-term exposure to
monopoly of atomic weapons lasted only until 1949 ionizing radiation was necessary. It also became
when the Soviet Union detonated its first atomic apparent to both the military and scientific
bomb, thereby starting the nuclear arms race. communities that they shared a common interest in
When a nuclear weapon explodes near the broadening the body of knowledge in this arena. A
ground, most of the energy goes into three effects. period of cooperation began between these two
Two of these are readily apparent and received most communities to develop the critically needed
of the initial focus of attention: the blast (shock knowledge about ionizing radiation. This document is
wave) and thermal energy (heat). Pictures of the a record of that cooperation and the research
aftermath of an atomic explosion portray the vast activities that were part of this joint search for
damage caused by these two effects. The vivid additional knowledge.
pictures of Hiroshima and Nagasaki after the atomic
bombing focused on the effects of blast and heat.
The third effect was completely new in the THE B EGINNING OF THE H UMAN RADIATION
annals of warfare: ionizing radiation. The short-term EXPERIMENT RECORD SEARCH EFFORT
effects of high-level exposures to ionizing radiation
generated by an atomic bomb were self-evident Even before the end of the Cold War in the early
because they led to almost immediate death. What 1990s, questions arose concerning U.S. Government
DOD REPORT ON SEARCH FOR HUMAN RADIATION EXPERIMENT RECORDS 1944-1994 xiii

involvement in human subject ionizing radiation focal point for this effort. Concurrently, President
research. In November 1986, U.S. Representative Clinton responded to growing public interest in this
Edward J. Markey of Massachusetts reported that the issue by establishing the ACHRE by EO on
U.S. Government had conducted experiments exposing 15 January 1994.3
humans to radioactive material.1 However, this report The ACHRE was charged with the responsibility
received relatively little public attention at the time. to:
Shortly after the end of the Cold War, there was
renewed interest about human subject experimentation • Review experiments conducted from 1944 to
that occurred during the Cold War era. In the early 1974 (later extended to 1994)
1990s, this interest began to accelerate. • Evaluate ethical and scientific standards and
In November 1993, the Albuquerque Tribune criteria on human radiation experiments
published a series of articles by reporter Eileen conducted or sponsored by the U.S.
Welsome citing a group of hospital patients who had Government
been injected with plutonium as part of a • Prepare a final report to the President on its
Government-sponsored research study begun before findings.
the end of World War II. In the same month, a
congressional report identified a number of cases of The year 1974 was originally established as the end
planned environmental releases of radiation at period because, on 30 May 1974, the Department of
nuclear weapons production sites after World War II.2 Health, Education, and Welfare (DHEW) (now
In early December 1993, Secretary of Energy Hazel Health and Human Services [HHS]) issued
O’Leary publicly stated that, in addition to regulations protecting human subjects in research.
conducting unannounced nuclear weapons tests, the The DoD also established the Radiation
U.S. Government may have used human subjects in Experiments Command Center (RECC) on
ionizing radiation research. 31 January 1994 under the direction of the
The Department of Energy (DOE) opened a ATSD(AE) to act as the central repository of records
national help line on 24 December 1993 to provide for the DoD effort. The RECC was charged with
the public with a means to submit reports of possible achieving a full accounting of DoD’s involvement in
or suspected experimental exposures. On 3 January any ionizing radiation research and experimentation
1994, the Human Radiation Experiments Interagency on human subjects during the past fifty years. The
Working Group was established, chaired by the RECC:
Secretary to the Cabinet and composed of the
Departments of Defense, Energy, Justice, Health and • Coordinated the DoD effort in the HRE records
Human Services, and Veterans Affairs, as well as the search with the services and DoD agencies
Central Intelligence Agency, the National • Conducted an extensive examination and
Aeronautics and Space Administration, and the review of relevant documents at the National
Office of Management and Budget. This group Archives and National Records Centers
focused its effort to identify ionizing radiation throughout the United States
experiments involving human subjects, hereafter • Coordinated the declassification of more
referred to as HRE. than 1,200 documents
In support of this initiative, Secretary of Defense • Initially identified approximately 2,600
Les Aspin, on 7 January 1994, instructed the DoD to possible DoD-sponsored projects or
compile information on the Department’s radiation experiments (a high number due to the
experiments. Secretary Aspin appointed the Assistant DoD policy to err on the side of inclusion
to the Secretary of Defense (Atomic Energy) to ensure full disclosure. Subsequently, this
(ATSD[AE]), Dr. Harold P. Smith, Jr., as the DoD number was reduced to 2,389 after
xiv DOD REPORT ON SEARCH FOR HUMAN RADIATION EXPERIMENT RECORDS 1944-1994

duplicates and erroneous submissions were On 2 November 1995, Dr. Smith further
identified.) amplified Secretary Perry’s reappointment
• Collected and forwarded copies of memorandum by stating that “the RECC has begun
approximately 10,000 records to the ACHRE initial work to publish a book to reflect DoD’s
• Coordinated the DoD’s review of the commitment to openness by summarizing what DoD
ACHRE’s draft Final Report to ensure found during its human radiation experiments
completeness and accuracy review.”5 This publication is the result of that effort.
• Participated in six congressional hearings as
well as several briefings on DoD-sponsored
activities. N OTES

Additionally, the RECC began an outreach 1. U.S. House of Representatives, Committee on Energy
program to respond to public inquiries. Under this and Commerce, Subcommittee on Energy Conservation
process, the RECC received DoD-related inquiries and Power, November 1986, “American Nuclear Guinea
forwarded by the DOE national help line, as well as Pigs: Three Decades of Radiation Experiments on U.S.
direct inquiries from the public, members of Citizens.”
Congress, and the White House. To date, the RECC
2. U.S. Senate, Committee on Governmental Affairs,
has received almost 7,000 inquiries. 11 November 1993, “Nuclear Health and Safety: Examples
After researching these inquiries, the RECC of Post World War II Radiation Releases at U.S. Nuclear
found that very few involved any human radiation Sites,” GAO/RCED-94-51-FS.
experimentation. Approximately 40 percent of the
inquiries involved U.S. atmospheric nuclear weapons 3. Presidential Documents, “Executive Order 12891 of
testing participants. The Defense Special Weapons January 15, 1994,” Federal Register, vol. 59, No. 13,
Agency (DSWA), formerly the Defense Nuclear 20 January 1994.
Agency (DNA), administers a separate program for
these participants called the Nuclear Test Personnel 4. Memorandum from the Secretary of Defense, Subject:
Response by the DoD to the Findings and
Review (NTPR) program. The RECC referred all
Recommendations of the ACHRE, dated 30 October
identified U.S. atmospheric nuclear weapons test 1995.
participants to the NTPR program.
A significant number of inquiries were related to 5. Memorandum from the Assistant to the Secretary of
approved and accepted medical procedures of the day. Defense (Atomic Energy), Subject: Response by the DoD
Other exposures occurred in occupational situations to the Findings and Recommendations of the ACHRE,
not related to human subjects research. There were dated 2 November 1995.
also a significant number of inquiries that did not
contain enough information from which to draw a
conclusion.
With release of the ACHRE Final Report and the
conclusion of the committee’s work on
3 October 1995, the DoD reaffirmed its commitment
to ensuring full and complete disclosure of its
involvement in any human radiation experiments.
On 30 October 1995, Secretary of Defense William J.
Perry reappointed Dr. Harold P. Smith, Jr.,
ATSD(AE), as the DoD focal point to continue the
efforts toward openness.4
CHAPTER
DOD HUMAN SUBJECTS
1 PROTECTION POLICY
1944 TO THE PRESENT
I NTRODUCTION (AFMPC), and the General Counsel’s (GC) office of
the Office of the Secretary of Defense (OSD) were all
The possibility of having to conduct combat substantively involved in formulating a policy for
operations on a battlefield contaminated by the using humans in research studies.1
effects of atomic, biological, or chemical weapons This initial human subjects protection policy debate
prompted the Department of Defense (DoD) to spanned 1942 to 1953 until the Wilson Memorandum
initiate research concerning the biomedical effects of established a formal policy. This directive required each
these agents on humans. This concern and that for military department to implement the policy as outlined
the safety of human volunteers in potentially in the memorandum. Thus, the Wilson Memorandum
dangerous research and the human experimentation set the standard for each service’s development of
atrocities revealed at the end of World War II were human subjects protection policy from 1953 through
driving forces behind the development of the DoD mid-1974. In May 1974, the Department of Health,
human subjects protection policy. These concerns Education, and Welfare (DHEW) issued its own
sparked years of serious debate among DoD and non- comprehensive regulations for DHEW human subject
DoD medical and scientific authorities regarding the research. These regulations were the foundation for
use of human participants in research. The today’s DoD human subjects protection policy.
culmination of this debate resulted in a written policy
in February 1953 by Secretary of Defense Charles E.
Wilson known as the Wilson Memorandum (see EVOLUTION OF D OD HUMAN SUBJECTS
figures 1, 2 and 3.) P ROTECTION POLICY
In the years before the Wilson Memorandum,
senior DoD officials and high-level DoD boards As early as 1942, concern regarding the
participated in developing DoD’s human subjects participation of human subjects in medical research
protection policy. For example,
the Nuclear Energy for the TERMS USED IN THIS CHAPTER
Propulsion of Aircraft/Medical
Advisory Committee on dosimetry measurement of the number of roentgens absorbed in
Radiation Tolerance of Military a single exposure to radiation
Personnel (NEPA/MAC), the ionizing radiation (see appendix 4 for discussion)
Committee on Medical Sciences
Radioisotope a radioactive isotope of a chemical element used in
(CMS), the Joint Panel on the
medical therapy, biological research
Medical Aspects of Atomic
Warfare (JPMAAW), the World War II WWII, 1939-1945, fought between the Allies (Great
Research and Development Britain, France, the Soviet Union, Canada, and the
Board (RDB), the Armed Forces United States as well as other nations) and the Axis
(Germany, Italy, Japan and other countries)
Medical Policy Council
1
2 Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present

ACRONYMS USED IN THIS CHAPTER and concern for their safety was
raised by the Committee on
ACHRE Advisory Committee on Human Radiation Experiments Medical Research of the Office
AEC Atomic Energy Commission [predecessor of the of Scientific Research and
Department of Energy] Development. During its forty-
second meeting on 29 October
AFMPC Armed Forces Medical Policy Council
1942, the committee stated:
AFR Air Force Regulation
that experiments on human
AFRRI Armed Forces Radiobiology Research Institute
beings were both desirable
AFSWP Armed Forces Special Weapons Project [predecessor and necessary in certain
to the Defense Special Weapons Agency] types of medical research re-
lated to the war effort; that the
AMA American Medical Association
subjects of such experiments
AR Army Regulation should be volunteers whose
attention had been called to
CMS Committee on Medical Sciences of the Research and
the dangers of the experiment;
Development Board
and that no categorical answer
DBM Division of Biology and Medicine (of the Atomic Energy could be given to the desirabil-
Commission) ity of experiments on human
beings in particular cases un-
DHEW Department of Health, Education, and Welfare
til after all the details of the pro-
DHHS Department of Health and Human Services posed experiments are placed
before the Committee.2
DNA Defense Nuclear Agency [now DSWA]
DoD Department of Defense The issues of informed consent
DSWA Defense Special Weapons Agency and institutional review were
central to the discussion.
GC General Counsel During the late 1940s, DoD
HURAD Human Use and Regulatory Affairs Division and the United States Air Force
(USAF) investigated the
IRB Institutional Review Board
possibility of developing a
JAG Judge Advocate General nuclear-powered aircraft, a
JCS Joint Chiefs of Staff program commonly referred to as
the Nuclear Energy for the
JPMAAW Joint Panel on the Medical Aspects of Atomic Warfare
Propulsion of Aircraft (NEPA)
LASL Los Alamos Scientific Laboratory, now Los Alamos project.
National Laboratory (LANL) In 1949, NEPA officials
NEPA/MAC Nuclear Energy for the Propulsion of Aircraft/Medical recommended conducting
Advisory Committee unclassified research on human
volunteers to study the
ONR Office of Naval Research
biological effects of radiation on
OSD Office of the Secretary of Defense the air crew of a nuclear-
RDB Research and Development Board powered aircraft.3 This
recommendation highlighted
TBI total-body irradiation
the need for a DoD-wide policy
USAF United States Air Force for using humans in research. At
USUHS Uniformed Services University of the Health Sciences a meeting of the NEPA/MAC
held on 3 April 1949, the
Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present 3

FIGURE 1 DOD ORGANIZATIONS INVOLVED IN THE DEVELOPMENT OF THE WILSON MEMORANDUM

Office of the Secretary


of Defense
(OSD)

Office of the Armed Forces Medical Research and


General Counsel Policy Council Development Board
(GC) (AFMPC) (RDB)

Committee on Committee on
Medical Sciences Atomic Energy
(CMS) (CAE)

Joint Panel on the


Medical Aspects of
Atomic Warfare
(JPMAAW)

committee argued that human experimentation was these types of exposures and no accurate dosimetry,
necessary for several reasons. First, animal which made it impossible to draw any definitive
experiments showed that animals of various species as conclusions.4
well as animals of different strains within a given In addition to providing these justifications for
species differed in their response to given amounts of human experimentation, the committee endorsed
radiation. Therefore, it would be impossible to three principles laid down by the Judicial Council of
predict accurately what would happen to humans the American Medical Association (AMA) in 1946
exposed to moderate doses of radiation. Second, to govern the use of humans in medical research:
although therapeutic exposures of radiation provided
some indications of how sick people responded, 1. The voluntary consent of the person on
patients’ responses varied depending on their clinical whom the experiment is to be performed
condition. Often, disease effects were must be obtained.
indistinguishable from radiation effects. Finally, 2. The danger of each experiment must have
accidental exposures and the mass exposures at been previously investigated by animal
Hiroshima and Nagasaki in Japan provided some experimentation.
indications of how healthy people responded to 3. The experiment must be performed under
radiation, but there were no scientific controls over proper medical protection and management.5
4 Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present

FIGURE 2 THE WILSON MEMORANDUM


Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present 5

FIGURE 2 THE WILSON MEMORANDUM (CONTINUED)


6 Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present

FIGURE 2 THE WILSON MEMORANDUM (CONTINUED)


Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present 7

FIGURE 3 WILSON MEMORANDUM TYPESET FROM ORIGINAL FOR LEGIBILITY


SECRETARY OF DEFENSE
Washington
26 Feb 1953
Memorandum for the SECRETARY OF THE ARMY
SECRETARY OF THE NAVY
SECRETARY OF THE AIR FORCE

SUBJECT: Use of Human Volunteers in Experimental Research

1. Based upon a recommendation of the Armed Forces Medical Policy Council, that human subjects be
employed, under recognized safeguards, as the only feasible means for realistic evaluation and/or development of
effective preventive measures of defense against atomic, biological or chemical agents, the policy set forth below
will govern the use of human volunteers by the Department of Defense in experimental research in the fields of
atomic, biological and/or chemical warfare.

2. By reason of the basic medical responsibility in connection with the development of defense of all types
against atomic, biological and/or chemical warfare agents, Armed Services personnel and/or civilians on duty at
installations engaged in such research shall be permitted to actively participate in all phases of the program, such
participation shall be subject to the following conditions:

a. The voluntary consent of the human subject is absolutely essential.

(1) This means that the person involved should have legal capacity to give consent; should be so
situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud,
deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge
and comprehension of the elements of the subject matter involved as to enable him to make an understanding
and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the
experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the
method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected;
and the effects upon his health or person which may possibly come from his participation in the experiment.

(2) The concept [sic: consent] of the human subject shall be in writing, his signature shall be affixed to a
written instrument setting forth substantially the aforementioned requirements and shall be signed in the presence
of at least one witness who shall attest to such signature in writing.

(a) In experiments where personnel from more than one Service are involved the Secretary of the
Service which is exercising primary responsibility for conducting the experiment is designated to prepare such an
instrument and coordinate it for use by all the Services having human volunteers involved in the experiment.

(3) The duty and responsibility for ascertaining the quality of the consent rests upon each individual who
initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated
to another with impunity.

b. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other
methods or means of study, and not random and unnecessary in nature.

c. The number of volunteers used shall be kept at a minimum consistent with item b., above.

d. The experiment should be so designed and based on the results of animal experimentation and a
knowledge of the natural history of the disease or other problem under study that the anticipated results will justify
the performance of the experiment.
8 Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present

FIGURE 3 TYPESET WILSON MEMORANDUM (CONTINUED)


e. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and
injury.

f. No experiment should be conducted where there is an a priori reason to believe that death or disabling
injury will occur.

g. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the
problem to be solved by the experiment.

h. Proper preparation should be made and adequate facilities provided to protect the experimental subject
against even remote possibilities of injury, disability, or death.

i. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill
and care should be required through all stages of the experiment of those who conduct or engage in the
experiment.

j. During the course of the experiment the human subject should be at liberty to bring the experiment to an
end if he has reached the physical or mental state where continuation of the experiment seems to him to be
impossible.

k. During the course of the experiment the scientist in charge must be prepared to terminate the experiment
at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful
judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the
experimental subject.

l. The established policy, which prohibits the use of prisoners of war in human experimentation, is continued
and they will not be used under any circumstances.

3. The Secretaries of the Army, Navy and Air Force are authorized to conduct experiments in connection with the
development of defenses of all types against atomic, biological and/or chemical warfare agents involving the use of
human subjects within the limits prescribed above.

4. In each instance in which an experiment is proposed pursuant to this memorandum, the nature and purpose of
the proposed experiment and the name of the person who will be in charge of such experiment shall be submitted
for approval to the Secretary of the military department in which the proposed experiment is to be conducted. No
such experiment shall be undertaken until such Secretary has approved in writing the experiment proposed, the
person who will be in charge of conducting it, as well as informing the Secretary of Defense.

5. The addresses [sic] will be responsible for insuring compliance with the provisions of this memorandum within
their respective Services.

/signed/
C. E. WILSON

Copies furnished:
Joint Chiefs of Staff
Research and Development Board

TOP SECRET Downgraded to UNCLASSIFIED


22 Aug 75
Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present 9

The NEPA recommendation initiated an intra- limitations on contaminated battlefields. Because


DoD and inter-agency debate on whether human other methods of obtaining these data were not
radiation experimentation was necessary. On 3 June useful, human studies were necessary. 11
1949, two months after NEPA/MAC’s meeting, the The CMS reconvened for its twelfth meeting on
JPMAAW held its first meeting. The panel discussed 23 May 1950 to review the JPMAAW reaffirmation of
the problem of human tolerance to radiation and the its original action. After deliberations, the committee
determination of maximum doses of radiation that passed the following motion:
the military would find acceptable. The panel stated
that it was desirable and necessary for the national The Committee on Medical Sciences endorses
defense to pursue human experiments on the effects the view that it is essential to obtain all neces-
of total-body irradiation to psychologically and sary scientific information concerning radiation
socially acceptable limits. The panel voted to table its doses and the effect on man by all means of
biological experimentation, as promptly as
decision pending the study of the NEPA report on
possible, including if necessary human experi-
the same subject. The panel also appointed a working ments under established principles of such
group to study and report on the issue and make experiments.12
recommendations on conducting research involving
human subjects.6 In addition, the NEPA/MAC recommendations
The JPMAAW met for the second time four received a firm endorsement from the Navy and a
months later on 7 October 1949. At that meeting, conditional endorsement from the Army. The Under
the working group presented the NEPA/MAC report Secretary of the Navy stated:
on human experimentation. The full panel endorsed
the NEPA/MAC recommendations, which included (1). Accurate experimental data on the biologi-
the AMA’s three principles.7 The panel then cal effects of known levels of radiation expo-
presented its recommendations to the CMS for sure in human subjects is essential for com-
approval. At its tenth meeting on 8 November 1949, plete knowledge of the problems involved. (2).
the CMS endorsed the action of the JPMAAW.8 It is believed that the procedures proposed by
During the months following this tenth meeting, the Chairman of the Subcommittee of the
some members of the CMS learned that the Atomic NEPA Medical Advisory Committee are sound
from a research point of view.13
Energy Commission’s (AEC) Division of Biology and
Medicine (DBM) did not favor human
The Army recognized the need to determine
experimentation.9 The AEC’s concerns prompted
radiation tolerances in humans but stated that such
the CMS to reconsider its endorsement. At its
experimentation presented significant difficulties and
eleventh meeting on 1 February 1950, the committee
dangers. In light of its reservations, Assistant
revoked its previous endorsement and voted to refer
Secretary of the Army Archibald S. Alexander
the issue of human experimentation back to the
recommended a more modest beginning than that
JPMAAW for further consideration.10 The panel
proposed by the NEPA/MAC. He commented:
immediately convened to reconsider its endorsement
of the NEPA/MAC recommendations and appointed
Significant progress has been made in pro-
another working group to reformulate panel opinion tecting animals against radiation injury by use
on the subject. The next day, the working group of certain endocrine products or chemicals
submitted its report and the JPMAAW reaffirmed its acting through the endocrine system. It is be-
position endorsing the use of human volunteers to lieved that these studies should be continued.
conduct experimentation. The JPMAAW maintained When it appears that reliance can be placed
that although the AEC’s civilian charter might not upon these findings, one or two cancer pa-
indicate a need for human experimentation, DoD tients, who must have intense radiation treat-
needed information on soldiers’ capabilities and ment for their condition, should be sought on
10 Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present

a volunteer basis to undergo what appears to discussion among the board, which concluded “that
be, from animal experimentation, the probable human experimentation was not justified and that
maximum tolerance level for man. If these sufficient information could be obtained from animal
acute experiments prove successful, and the experimentation and interpolation from clinical
treatment methods as good as prior experi-
data.”19
mental results indicate, then it is recom-
mended that consideration be given to
By the end of 1950, the DoD and the AEC
establishing a significant experiment to agreed not to move forward with a human research
validate the limits of human tolerance to program or detailed policy. Throughout 1951, the
radiation.14 consensus remained that human research was not
indicated at that time. M. C. Leverett, Technical
In a 13 April 1950 memorandum, Air Force Director of the NEPA project, announced the
Surgeon General Harry G. Armstrong did not concur discontinuation of “efforts to obtain governmental
with the recommendations of the NEPA/MAC that approval for experiments on humans along the lines
the Armed Services arrange for experimentation on recommended by our [NEPA] Advisory
humans. He stated that radiation was not solely a Committee.”20
military threat but had civilian repercussions as well. The DoD funded some observational studies on
Because General Armstrong viewed radiation patients who were receiving doses of radiation as part
research as both a civilian and a military problem, he of a therapeutic procedure. Beginning in 1951, the
concluded that the AEC, whose interests Air Force funded post-treatment observational
encompassed civilian and military areas, should be studies at the MD Anderson Hospital and Tumor
the agency primarily responsible for any research Clinic of Houston, Texas. The Air Force provided
program.15 funds for data collection on the physical symptoms of
In a memorandum dated 8 August 1950, the radiation sickness and the effects of radiation on
Director of Medical Services for the DoD, Richard L. psychomotor capabilities. Air Force funds were not
Meiling, M.D., agreed with General Armstrong’s used for radiation treatments or other patient care. In
assessment and stated the DoD position: a description of the MD Anderson study before it
began, the Air Force explained its involvement in
The research program required to develop the civilian programs in the following statement:
necessary scientific information concerning
radiation doses involves both civilian and mili- It is desired to measure certain mental and
tary problems. Hence, it is considered to be a psychomotor abilities of patients who are un-
problem for the Division of Biology and Medi- dergoing radiation therapy in order to evalu-
cine of the Atomic Energy Commission.16 ate any differences in performance that may
result from radiation effects. This information
However, at its sixth meeting held 31 October to is urgently required by the U.S. Air Force in
1 November 1950, the JPMAAW approved by a connection with the NEPA Project. It is clear
majority vote a motion to continue its efforts to that before attempting to operate its proposed
secure approval for human research.17 nuclear powered aircraft, the U.S. Air Force
must evaluate its radiation hazards. There are
Members of the Advisory Board of the DBM met
no scientific data with which to assess these
on 10 November 1950 with representatives from the dangers of the NEPA aircraft in terms of their
Surgeon General’s offices of each branch of the probable effects upon crew performance and
military. During the meeting, Army Brigadier well-being. The most direct approach to this
General James P. Cooney “proposed human information would be by human experimenta-
experimentation on a group of 200 service volunteers tion in specifically designed radiation studies;
to determine the effects of operational effectiveness however, for several important reasons, this
to dosages of total body radiation within presumably had been forbidden by top military authority.
low safe zones [sic].”18 The proposal generated Since the need is pressing, it would appear
Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present 11

mandatory to take advantage of investigation counter suspected Soviet advances in biological and
opportunities that exist in certain radiological chemical warfare. Intra-agency discussions during
centers by conducting special examinations and 1952 focused on writing a detailed human subjects
measures of patients who are undergoing protection policy. On 8 April 1952, the AFMPC, a
radiation treatment for disease. While the
DoD organization established in January 1951,
flexibility of experimental design in a radiologi-
cal clinic will necessarily be limited, the informa-
requested that any directives or statements of policy
tion that may be gained from the studies of issued to the branches of the military as guidelines
patients is considered potentially invaluable; using humans in studies be forwarded to the AFMPC
furthermore, this is currently the sole source of for information and study.23 The deliberations
human data.21 throughout 1952 provided the foundations and
framework for a definitive DoD human subjects
(See chapter 2 for more information on the MD protection policy.
Anderson study.) Many circulating internal DoD letters and
A belief in the necessity for guiding principles for memoranda referred to changes, additions, or
these types of studies persisted. In a letter to Leslie M. suggestions for the proposed DoD human subjects
Redman, Los Alamos Scientific Laboratory (LASL,) protection policy. On 13 October 1952, Stephen S.
(now Los Alamos National Laboratory [LANL]), Jackson, Counsel to the AFMPC, submitted a
dated 5 March 1951, Shields Warren, M.D., Director memorandum to the Director of the AFMPC, Melvin
of the DBM for the AEC, informed Mr. Redman of A. Casberg, M.D., recommending that the council
the guiding principles the AEC followed regarding adopt, as the DoD human subjects protection policy,
human experimentation. the principles and conditions set forth in the
Nuremberg Code (see box, “The Nuremberg Code,”
We believe that no substances known to be, next page).24 In addition, Mr. Jackson recommended
or suspected of being, poisonous or harmful the language, “Whereas prisoners incarcerated in
should be given to human beings unless all of penal institutions may and have been used if the
the following conditions be fully met: (a) that a required conditions are met, prisoners of war will not
reasonable hope exists that the administra-
be used in human experimentation.”25 Mr. Jackson
tion of such a substance will improve the con-
dition of the patient, (b) that the patient give
later amended this proposed language in a follow-up
his complete and informed consent in writing, memorandum dated 4 December 1952, removing the
and (c) that the responsible nearest of kin give first part of the sentence so it read, “Prisoners of war
in writing a similarly complete and informed will not be used in human experimentation.”26
consent, revocable at any time during the In a 22 October 1952 memorandum to
course of such treatment.22 Dr. Casberg, Mr. Jackson passed along a
recommendation from the Assistant Secretary of
This statement reflects the AEC’s human subjects Defense for Manpower, Anna Rosenberg, “that a
protection policy in 1951. As mentioned before, the provision be added requiring that the consent be
DoD’s decision in August 1950 to defer to the AEC expressed in writing before at least one witness.”27
on this matter made the AEC policy de facto DoD This language was approved by the OSD GC.
policy. At a 30 - 31 October 1952 meeting, the CMS
By early 1952, the JPMAAW and the CMS again discussed the problem of human experimentation and
reexamined the need for a human subjects protection appointed an ad hoc working group to study the
policy. Although the original debate had been merits of issuing a policy statement.28 A
initiated by a perceived need to conduct biomedical memorandum dated 24 December 1952 from
research related to ionizing radiation, the major Dr. Casberg to the Secretary of Defense reported that
impetus in 1952 for developing the DoD’s human the AFMPC recommended that a policy be
subjects protection policy stemmed from the need to established for using human volunteers in
12 Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present

THE NUREMBERG CODE


1. The voluntary consent of the human subject is absolutely essential. This means that the person
involved should have legal capacity to give consent; should be so situated as to be able to exercise free
power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or
other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the
elements of the subject matter involved as to enable him to make an understanding and enlightened
decision. The latter element requires that before the acceptance of an affirmative decision by the
experimental subject there should be made known to him the nature, duration, and purpose of the
experiment; the method and means by which it is to be conducted; all inconveniences and hazards
reasonably to be expected; and the effects upon his health or person which may possibly come from his
participation in the experiments. The duty and responsibility for ascertaining the quality of the consent rest
upon each individual who initiates, directs or engages in the experiment. It is a personal duty and
responsibility which may not be delegated to another with impunity.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by
other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal experimentation and a
knowledge of the natural history of the disease or other problem under study that the anticipated results will
justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering
and injury.
5. No experiment should be conducted where there is an a priori reason to believe that death or
disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also
serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance
of the problem to be solved by the experiment.
7. Proper preparation should be made and adequate facilities provided to protect the experimental
subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of
skill and care should be required through all stages of the experiment of those who conduct or engage in the
experiment.
9. During the course of the experiment the human subject should be at liberty to bring the experiment
to an end if he has reached the physical or mental state where continuation of the experiment seems to him
to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the
experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill,
and careful judgment required of him, that a continuation of the experiment is likely to result in injury,
disability, or death to the experimental subject.

experimental research. In addition, the AFMPC office drafted what would become the Wilson
recommended “that the ten rules promulgated at the Memorandum. By the end of 1952, most of the
Nuremberg Trials be adopted as the guiding principles deliberations on the use of humans in research had
to be followed.”29 (For explanation of the Nuremberg concluded, and recommendations were ready to be
Trials, see box, “The Nuremberg Trials,” next page.) passed on to Secretary of Defense Robert Lovett for
Dr. Casberg also included the statement regarding approval and distribution. However, 1952 was an
prisoners of war suggested by Mr. Jackson as part of election year and a new administration was about to
the recommendation from AFMPC.30 take office in 1953. In light of the change in
Throughout 1952 and early 1953, the JPMAAW, administration, final approval was delayed. The
the AFMPC, the CMS, and members of the GC’s Director of the Executive Office of the OSD,
Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present 13

Col. G. V. Underwood, asked


THE NUREMBERG TRIALS
Dr. Casberg to hold the matter “for
safe keeping with the understanding As early as 1943 the United States, Great Britain, and the
that at an appropriate time, after Soviet Union agreed that at the conclusion of World War II they
the installation of the new would prosecute individuals who may have violated international
Administration, the matter will be law during the war. Shortly after the end of the war, representatives
brought up again.”31 The reasoning from the American, British, French, and Soviet governments
behind the delay was simply that established the International Military Tribunal in Nuremberg,
the incoming Secretary of Defense Germany on 8 August 1945. The tribunal was composed of a panel
would ultimately have responsibility of international judges; the purpose was to provide a forum for
Allied prosecutors to present cases against German government
for administering the policy.
and military officials and Nazi party members charged with wartime
atrocities. The subsequent trials came to be known as the
Nuremberg trials. A first set of trials ran from October 1945 to
THE WILSON MEMORANDUM
October 1946.
A second set of trials began on 9 December 1946. The first of
The new Secretary of Defense, these trials was officially called United States v. Karl Brandt et al.,
Charles E. Wilson, signed a but was commonly referred to as “The Doctors’ Trial,” “The Medical
memorandum on 26 February 1953 Case,” and the “Nuremberg Medical Trial.” The prosecutors in this
that finally established a DoD case charged that the defendants were responsible for murders,
human subjects protection policy.32 tortures, and other atrocities committed in the name of medical
This policy, based on the principles science.
defined in the Nuremberg Code, At the conclusion of the case on 19 August 1947, the judges
required the written consent of the handed down, along with seven death sentences, a ruling that has
come to be known as the Nuremberg Code. This code formally set
research subject and prohibited the
standards, in practice at the time, governing the use of humans in
use of prisoners of war in human medical experimentation. The Nuremberg Code also served as a
experimentation. This policy starting point for DoD’s human use policy.
applied to human volunteers only
in the fields of atomic, biological,
and chemical warfare research.
The Wilson Memorandum was classified Top day after Secretary Wilson issued the human subjects
Secret, which was consistent with other memoranda protection policy, Director of Administration for the
conveying information related to weapons of mass RDB, Astrid Kraus, requested permission (which was
destruction. However, that classification limited its denied) from the Director, Executive Office, OSD,
distribution. The memorandum was addressed only to to reproduce the Wilson Memorandum for five RDB
the Secretaries of the three branches of the military, committees directly concerned with the human
and copies were furnished to the Joint Chiefs of Staff subjects protection policy.33 In addition, legal
(JCS) and the RDB. interpretations of the memorandum were requested
on at least two occasions. At its eighteenth meeting
on 26 - 27 February 1953, the CMS passed a motion
Dissemination and Implementation of the requesting “the official legal interpretation of all the
Wilson Memorandum clauses of the document and the rationalization of
apparent discrepancies.”34 On 16 April 1953, the
Despite the restrictive classification attached to Chief of Research and Development of the Army
the memorandum, efforts were made to forward the General Staff asked the Judge Advocate General’s
information to other organizations within the DoD. (JAG) office to express an opinion on the Wilson
In a memorandum dated 27 February 1953, just one Memorandum.35
14 Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present

Dissemination and implementation within the conducting contract research,”45 neither document
branches of the military fell to the individual branch specifically stated that the policy applied as a
Secretaries and thus varied from service to service. mandatory policy to contractors.
Within the Army, a 30 March 1953 memorandum As a result of inquiries by several Senate
from Lt. Gen. L. L. Lemnitzer, Deputy Chief of Staff committees, the Secretary of the Army directed
for Plans and Research, to the Secretary of the Army eighteen years later that research be conducted to
indicated that the Wilson Memorandum had been determine the Army’s role in hallucinogenic drug
distributed to the Chief of Research and research. A portion of this report focused on the
Development, Office of the Chief of Staff; Deputy Army’s implementation of its human use policy. This
Chief of Research and Development, Office of the 1975 Army Inspector General’s Report, “Use of
Chief of Staff; Deputy Assistant Chief of Staff, G-4, Volunteers in Chemical Agent Research,” suggested
for Research and Development; Chief Chemical that Army implementation of the Wilson human use
Officer; The Surgeon General; Assistant Chief, policy had been inconsistent.46
Research and Development Division; and Chairman, No documentation was located during the HRE
Medical Research and Development Board.36 review to verify distribution or implementation of the
Furthermore, a memorandum dated 12 May 1953 Wilson Memorandum within the Navy below the
from a biochemist at the Toxic Chemical Warfare level of the Secretary of the Navy. However, by
branch of the Army Chemical Corps37 indicated that 1953, the Navy already had a long history of
the policies contained in the Wilson Memorandum requiring Secretarial approval before conducting
had been disseminated down to the level of experiments with human subjects. For example, in
researchers. 1932, the Secretary of the Navy approved a study
By 30 March 1953, the Army proposed a draft using divers with the condition that the participants
directive designed to implement the Wilson be informed volunteers, and by 1943, the Secretary of
Memorandum for Army-conducted human the Navy required that all research involving service
experimentation.38 The draft policy received personnel be approved by the Secretary.47 By 1951,
endorsements from the Army Surgeon General39 and the Navy recorded its policy on human
the Chief Chemical Officer.40 By late April 1953, the experimentation in the “Manual of the Medical
Army JAG was reviewing the draft directive’s legal Department.” This policy required that:
implications.41 On 20 May 1953, Secretary of the
Army Robert Stevens approved the 30 March draft [e]xperimental studies of a medical nature in-
policy on using humans in experimental research in volving persons in the Naval Establishment are
light of Secretary Wilson’s 26 February directive. In forbidden except when the experimental de-
addition, he “requested that the security classification sign in each case has received the prior ap-
proval of the Secretary of the Navy. . . . Par-
of this subject be reviewed to determine if it cannot
ticipation by personnel of the Naval
be downgraded” in an attempt to further disseminate Establishment (military and civilian) shall be
Secretary Wilson’s directive.42 on a voluntary basis only.48
Further clarification of the Army policy resulted
from a 30 June 1953 Army Chief of Staff In addition, the policy required the Bureau of
memorandum43 and a 12 March 1954 Army Surgeon Medicine and Surgery to review all studies before
General memorandum.44 Both documents raised the submission to the Secretary of the Navy.49
issue of whether Secretary Wilson’s policy as Within the Air Force, the policy was forwarded
implemented by the Secretary of the Army applied to by 10 March 1953 to the Inspector General; Deputy
contract research. Although the Army Surgeon Chief of Staff, Development; Director of Operations;
General’s memorandum stated that the human Director of Plans; Deputy Chief of Staff, Personnel;
subjects protection policy was “to be used as far as and Deputy Chief of Staff, Materiel.50 However, no
applicable as a non-mandatory guide for planning and other documentary evidence indicated further
Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present 15

distribution or implementation of the Wilson Navy Manual of the Medical Department in 1951. In
Memorandum. 1967, a requirement for written consent, which did
Questions remain on whether DoD components not distinguish between research on patients and
directly involved with atomic issues, such as the research on healthy subjects, was added to the
Armed Forces Special Weapons Project (AFSWP) manual.52 In 1969, two years later, the Secretary of
(predecessor to the Defense Special Weapons Agency the Navy issued a comprehensive policy that covered
[DSWA] and an organization that reported directly to both groups and included a requirement for written
the JCS), were notified of the Wilson Memorandum. informed consent from research subjects.53
AFSWP personnel were aware as early as November In addition to the military departments, the
1953 that a DoD human subjects protection policy Department of Health, Education and Welfare
had been established;51 however, no indication is (DHEW), on 30 May 1974, published a
available that the policy was formally transmitted comprehensive human subjects protection policy that
from OSD or implemented by AFSWP. provided a framework for subsequent human subjects
protection policies for many Government agencies,
including the DoD. The regulations required each
EVOLUTION OF POLICIES AND R EGULATIONS institution requesting research funds from DHEW to
form a committee to approve all research proposals
Each branch of the military began issuing its own before they were submitted. These committees came
policies and regulations to govern human to be known as Institutional Review Boards (IRBs)
experimentation as a result of increasing concern for and were responsible for ensuring the overall safety of
protection of human research subjects. the proposed projects and the adequacy of the
informed consent obtained from each subject before
Army. A formal Army Regulation (AR 70-25) participation in the project. In addition, the
was issued in 1962 and incorporated the policies set regulations defined the criteria for informed consent
forth in the Wilson Memorandum. It applied to all and detailed the procedures for obtaining informed
types of research, not just research related to atomic, consent. Although the regulations applied only to
biological, and chemical warfare and specifically research funded by DHEW, the policy was an
excluded clinical research. The following year, the important step in the development of Federal
Army issued a regulation for radioisotope use that standards for human subject research and provided
required local institutions to appoint review the framework for current DoD human subjects
committees. These review committees were required protection policies. Following the adoption of this
to obtain approval from the Secretary of the Army policy, other Government agencies began to develop
when radioisotopes were to be used with volunteer their own human subjects protection policies using
experimental subjects. Clinical investigations the DHEW policy as a foundation.
continued to be excluded from AR 70-25 until 1973
when the Army issued AR 40-38 which specifically Air Force. Before the Wilson Memorandum, one
applied to clinical investigations involving either of the early Air Force Regulations (AFR 80-22, dated
patients or healthy subjects. The regulation restated 11 July 1952) required the officer conducting the
the requirement for informed consent and required research to provide justification for the investigation,
that clinical research be reviewed by a human use background references, research design, and lines of
committee. authority; however, there was no mention of consent
requirements. The regulation was revised in July
Navy. As noted earlier, the Navy had a history, 1956, September 1960, and January 1963. In April
before the Wilson Memorandum, of requiring 1963, AFR 80-22 was superseded by AFR 169-6. In
informed consent and secretarial review of research addition to the requirements in AFR 80-22, AFR
projects. These policies were first recorded in the 169-6 required the Surgeon General to approve all
16 Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present

clinical investigation protocols. By April 1968, a human subjects must comply with the regulations of
revision of AFR 169-6 created the Surgeon General’s the Food and Drug Administration.
Clinical Investigation Committee and a review board Human subjects protection oversight within
for investigational drugs. Like AFR 80-22, the DoD currently resides with the Director,
AFR 169-6 did not mention informed consent. Defense Research and Engineering (DDR&E), who
However, approximately two years later, in October develops policies in coordination with the
1965, a new regulation, AFR 169-8, stated that Assistant Secretary of Defense (Health Affairs).
informed consent was absolutely essential and Operational oversight has been delegated to the
required in writing. The regulation further required individual military departments or defense agencies
that participants be informed of the study’s nature, through the Director, Environmental and Life
duration, purpose, methods, inconveniences, hazards, Sciences of the office of DDR&E. Within the
and effects on health. Moreover, AFR 169-8 directed various service components or agencies, human
the commander of the facility conducting the subjects protection is implemented at biomedical
research to appoint a research committee. This research and development facilities and at medical
research committee was charged with reviewing all treatment facilities conducting clinical
human use protocols and recommending approval or investigations. With minor exceptions, both the
disapproval. If the protocol received approval from biomedical research and development programs
the local research facility, it was then sent to the and clinical investigation efforts of the military
Surgeon General for approval before the departments come under the purview of each
investigation started. This regulation was revised in service’s Surgeon General.
May 1968 and August 1974. In September 1976,
AFR 169-8 was incorporated into AFR 169-6.
Clinical Investigations Programs

CURRENT DOD POLICY FOR HUMAN SUBJECTS Primary responsibility for oversight of human
P ROTECTION medical research resides with each hospital
commander whose facility sponsors a clinical
The authority for oversight of human subjects investigation program. Oversight is exercised
protection within the DoD is established within the primarily through the Chief of the Department of
reporting chain of command. Title 32, Code of Clinical Investigations at each major teaching
Federal Regulations, Part 219 (32 CFR 219), Federal hospital. These chiefs also use the deliberations and
Policy for the Protection of Human Subjects (the contributions of human use protection (IRBs),
DoD version of the Federal “Common Rule,” a copy clinical investigations, radiation protection,
of which is provided in appendix 2, exhibit 1), and pharmacy and therapeutics, and quality assurance
Title 10, United States Code, Section 980 (10 U.S.C. committees. Independent medical monitors (health
980) establish the fundamental regulatory care providers qualified by training, experience, or
requirements for human subjects protection. both) are appointed for most studies that involve
Execution of these regulations and written standards more than minimal risk to monitor human subjects
for performance are found in DoD Directive 3216.2, during the research and to ensure the ongoing
Protection of Human Subjects in DoD Supported protection of human subjects involved in each
Research, in DoD Guidance for the Assurance of project. An annual review of each human subjects
Compliance with the Federal Policy for the research protocol is required. Also, each service
Protection of Human Subjects,54 and in the conducts headquarters-level reviews of all clinical
implementing regulations and instructions of the human subjects protocols involving more than
military departments and agencies.55 Additionally, minimal risk. Each service has a central office that
research involving a new drug or medical device in provides human subjects protection oversight and
Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present 17

coordination among its hospitals that perform human Research and Development Command
subjects research. These central offices are as follows: (NMRDC), Bethesda, Maryland, exercises
oversight for all human subjects research
• Army. The Clinical Investigation Regulatory conducted by both uniformed and civilian
Office (CIRO), U.S. Army Medical Navy personnel, as well as contractors. The
Department Center and School, Fort Sam Office of Naval Research (ONR) also
Houston, Texas supports contracted research activities
involving human subjects. Under authority of
• Navy. The Clinical Investigations Program the Chief of Naval Research, the Head,
Office, Naval School of Health Sciences, Personnel Optimization and Biomolecular
Bethesda, Maryland Science and Technology Department, is
responsible for human subjects protection
• Air Force. The Headquarters, Air Force oversight.
Medical Operations Agency, Office of the
Surgeon General (HQ AFMOA/SGOT), • Air Force. Headquarters, Air Force Medical
Bolling Air Force Base, Washington, D.C. Operations Agency, Office of the Surgeon
General (HQ AFMOA/SGOT), Bolling Air
Force Base, Washington, D.C., is the central
Biomedical Research and Development office that oversees human subjects
Programs protection at Air Force research and
development facilities performing human
The commanding officers of the military subjects research.
biomedical laboratories or institutes are ultimately
responsible for local institutional oversight. • Uniformed Services University of the Health
Commanders use several review committees to Sciences (USUHS). Within the USUHS,
exercise their responsibilities regarding scientific oversight for human subjects protection is the
integrity and protection of human subjects. The responsibility of the Dean, School of
principal committees for protocol reviews are the Medicine, and the Dean, Graduate School of
scientific review committees and the human use Nursing. The USUHS Research
review committees or IRBs. Independent medical Administration Office coordinates the
monitors are appointed for each study that involves oversight and review of human subjects
more than minimal risk: research protocols by the USUHS IRB.

• Army. The Human Use and Regulatory • Armed Forces Radiobiology Research
Affairs Division (HURAD) of the Office of Institute (AFRRI). The Director of AFRRI
the Deputy Chief of Staff for Regulatory is ultimately responsible for all research
Compliance and Quality, U.S. Army Medical activities conducted or sponsored by the
Research and Materiel Command Institute. AFRRI reports through the
(USAMRMC), Fort Detrick, Maryland, USUHS and therefore uses the USUHS
exercises protocol review oversight for all oversight and review committees for research
human subjects research conducted by both involving human subjects.
uniformed and civilian Army personnel, as
well as contractors. • Defense Special Weapons Agency (DSWA).
Protocol review and project oversight occur
• Navy. The Committee for the Protection of through the appropriate office of the
Human Subjects within the Naval Medical participating military service.
18 Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present

The functions of the various offices are of compliance must have one or more IRBs
conducted in accordance with requirements established and duly constituted under the provisions
delineated in 32 CFR 219. The other offices of the Federal Common Rule. Continuing reviews of
described by the services or agencies function as the research programs involving human subjects are
regulatory offices to ensure compliance with the vested in the IRBs and are conducted at intervals
requirements of the Federal Common Rule and other appropriate to the level of risk, but at least annually.
regulations and policy guidance. The headquarters- Department-sponsoring components require that
level oversight offices review, monitor, and inspect reports of the continuing reviews be filed with
the programs under their authority. The various headquarters-level review boards for further
oversight offices ensure that accurate records of all inspection. Component sponsors also perform on-site
research protocols (including study design), reviews of selected grantee or contractor institutions;
investigator credentials, approved informed consent however, limited personnel and budgets do not allow
forms, compliance and assurance documents, progress on-site reviews of all extramural programs. All
reports, and minutes of IRB or Human Subject reviews, inspections, and site visits are documented.
Review Board (HSRB) transactions (including Permanent records of such inspections or reviews are
meeting minutes) are maintained. In addition, the maintained by the office conducting or sponsoring
oversight offices coordinate the collection and the inspection or review.
dissemination of information essential in conducting In its Final Report, the Advisory Committee on
reviews of research protocols involving human Human Radiation Experiments (ACHRE) listed a
subjects and serve as central locations for access to number of recommendations specifically directed to
local, State, and Federal regulations and to directives the protection of the rights and interests of human
and policies about research involving human subjects in the future. The DoD will implement
subjects. The oversight offices also serve as the several of these recommendations through revision of
central point for information about program its policy directives and the implementing regulations
management and operations within their respective and instructions of the military departments and DoD
service or agency. agencies. Others are beyond the scope of DoD
The services conduct announced and regulations and may require amendment of the
unannounced site visits to facilities to evaluate Federal Common Rule or legislative action. Some
program management and to monitor compliance deal with broad, overarching ethical considerations
with regulations. Since 1993, the services have and will fall under the purview of the newly created
conducted more than 180 such visits by local or National Bioethics Advisory Commission (NBAC).
headquarters authorities of facilities conducting
human subjects research. This number does not
include all of the internal quality assurance N OTES
committee monitoring programs or periodic
administrative and record keeping audits that are (To obtain copies of the following documents, see appendix 2.)
conducted.
DoD policy and Federal regulations (32 CFR 1. Directive, Committee on Medical Sciences,
219) require institutions, either foreign or domestic, 11 February 1948. This directive established the
Committee on Medical Sciences as an agency of the
that conduct human subjects research sponsored by
Research and Development Board; Directive, Joint Panel
the DoD components to hold an assurance of
on Medical Aspects of Atomic Warfare, 23 February 1949.
compliance with the human subjects protection This directive established the Joint Panel on Medical
regulations of the Department of Health and Human Aspects of Atomic Warfare as a joint agency of the
Services (DHHS) (45 CFR 46) or negotiate an Committee on Medical Sciences and the Committee on
equivalent assurance with the DoD component Atomic Energy; Directive for the Armed Forces Medical
concerned. Accordingly, institutions with assurances Policy Council, 2 January 1951. This directive established
Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present 19

the Armed Forces Medical Policy Council, which Services, Office of the Secretary of Defense, Subject:
reported directly to the Secretary of Defense. “Recommendation That the Armed Services Conduct
Experiments on Human Subjects to Determine Effects of
2. Minutes, Forty-Second Meeting of the Committee on Radiation Exposure,” 3 May 1950.
Medical Research of the Office of Scientific Research and
Development, 29 October 1942, p. 4. 15. Memorandum, from Maj. Gen. Harry G. Armstrong,
USAF, the Surgeon General, to General Powell, Subject:
3. Minutes, Second Meeting of the NEPA/MAC on “Recommendation That the Armed Services Conduct
Radiation Tolerance of Military Personnel, 3 April 1949, Experiments on Human Subjects to Determine Effects of
pp. 4–5. Radiation Exposure,” 13 April 1950.

4. Ibid, pp. 3–4. 16. Memorandum, from Richard L. Meiling, M.D.,


Director of Medical Services, Office of the Secretary of
5. Ibid, p. 4. Defense, to The Honorable Gordon E. Dean, Chairman of
the AEC, 8 August 1950.
6. Minutes, First Meeting of the JPMAAW, 3 June 1949,
p. 5. 17. Minutes, Sixth Meeting of the JPMAAW, 31 October
to 1 November 1950, p. 6.
7. Minutes, Second Meeting of the JPMAAW, 7 October
1949, p. 4. 18. Meeting summary for the Advisory Board of the AEC
DBM, 10 November 1950, p. 2.
8. Memorandum, from James E. McCormack, M.D.,
Executive Director, CMS, to Astrid Kraus, Director of 19. Ibid.
Administration, RDB, Subject: “Problem of
Experimentation with Human Volunteers,” 25 July 1950, 20. Letter, from M. C. Leverett, Technical Director,
p. 2. NEPA Project, to Shields Warren, M.D., Director of the
AEC DBM, 15 February 1951, p. 1.
9. Letter, from Wallace O. Fenn, to Dr. James E.
McCormack, Executive Director, Committee on Medical 21. Project Specifications for “A Study of Intellectual,
Sciences, 5 December 1949, and Letter, from Dr. James E. Perceptual, and Psychomotor Abilities of Patients
McCormack, Executive Director, Committee on Medical Following Radio-Therapy,” p. 1, Attached to
Sciences, to Dr. Joseph C. Aub, 7 December 1949. Memorandum, from Lt. Lando Haddock, USAF, to
Commanding General, Air Materiel Command, Wright-
10. Memorandum, from James E. McCormack, M.D., Patterson Air Force Base, Subject: “Negotiation of Cost
Executive Director, CMS, to Astrid Kraus, Director of Reimbursement Contract,” 19 October 1950.
Administration, RDB, Subject: “Problem of
Experimentation with Human Volunteers,” 25 July 1950, 22. Letter, from Shields Warren, M.D., Director of the
p. 2. AEC DBM, to Leslie M. Redman, “D” Division, LANL,
5 March 1951, p. 1.
11. Minutes, Fourth Meeting of the JPMAAW,
16-17 February 1950, p. 5, Appendix C. 23. Memorandum, from Melvin A. Casberg, M.D.,
Chairman of the AFMPC, to Secretary of the Army,
12. Memorandum, from James E. McCormack, M.D., Secretary of the Navy, Secretary of the Air Force, and
“Problem of Experimentation with Human Volunteers,” Chairman, CMS RDB, Subject: “Policy and Procedures in
pp. 2-3. Connection with the Use of Human Beings as Subjects in
Experimentation,” 8 April 1952.
13. Memorandum, from Under Secretary of the Navy, to
the Secretary of Defense, 24 April 1950. 24. Memorandum, from Stephen S. Jackson, Counsel to
the AFMPC, to Melvin A. Casberg, M.D., Subject: “The
14. Memorandum, from Archibald S. Alexander, Standards and Requirements To Be Followed in Human
Assistant Secretary of the Army, to Director of Medical Experimentation,” 13 October 1952.
20 Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present

25. Ibid. 37. Memorandum, from E. S. Josephson, Biochemist,


TCW Branch, Army Chemical Corps, to Chief, BW
26. Memorandum, from Stephen S. Jackson, Counsel to Branch, Army Chemical Corps, Subject: “Status of Use of
the AFMPC, to Melvin A. Casberg, M.D., Chairman of Human Volunteers in TCW,” 12 May 1953.
the AFMPC, Subject: “The Standards and Requirements
To Be Followed in Human Experimentation,” 4 December 38. Memorandum, from Col. R. B. Firehock, General
1952. Staff Assistant, to Chief Chemical Officer, the Army
Surgeon General, Subject: “Use of Volunteers in
27. Memorandum, from Stephen S. Jackson, Counsel to Experimental Research,” 31 March 1953.
the AFMPC, to Melvin A. Casberg, M.D., Chairman of
the AFMPC, 22 October 1952. 39. Memorandum, from Maj. Gen. George E. Armstrong,
The Surgeon General, to Chief of Research and
28. Memorandum, from F. Lloyd Mussells, M.D., Development, Office of the Army Chief of Staff, Subject:
Executive Director of the CMS, to Dr. Floyd L. Miller, “Use of Human Volunteers in Experimental Research,”
Vice Chairman of the CMS RDB, Subject: “Human 9 April 1953.
Experimentation,” 12 November 1952.
40. Memorandum, from Col. Marshall Stubbs, Chemical
29. Memorandum, from Melvin A. Casberg, M.D., Corps, Chief, Research and Development Division, to
Chairman of the AFMPC, to the Secretary of Defense, Chief of Staff, U.S. Army, Subject: “Use of Human
Subject: “Use of Human Volunteers in Experimental Volunteers in Experimental Research,” 10 April 1953.
Research,” 24 December 1952.
41. Memorandum, from Col. R. B. Firehock, General
30. Ibid. Staff Assistant, to The JAG, U.S. Army, Subject: “Use of
Volunteers in Research,” 16 April 1953.
31. Memorandum, from Col. G. V. Underwood, U.S.
Army, Director, Executive Office of the OSD, to Melvin 42. Memorandum, from Robert T. Stevens, Secretary of
A. Casberg, M.D., Chairman of the AFMPC, Subject: the Army, to Chief of Staff, U.S. Army, 20 May 1953.
“Use of Human Volunteers in Experimental Research,”
9 January 1953. 43. Memorandum, from Brig. Gen. John C. Oakes,
Secretary of the General Staff, to Chief Chemical Officer
32. Memorandum, from Secretary of Defense C. E. of the Surgeon General, Subject: “Use of Volunteers in
Wilson, to Secretary of the Army, Secretary of the Navy, Research,” 30 June 1953.
Secretary of the Air Force, Subject: “Use of Human
Volunteers in Experimental Research,” 26 February 1953. 44. Memorandum, from Army Surgeon General, Subject:
“Use of Human Volunteers in Medical Research,
33. Memorandum, from Astrid Kraus, Director of Principles, Policies, and Rules of the Office of the Surgeon
Administration of the CMS RDB, to Director, Executive General,” 12 March 1954.
Office, OSD, 27 February 1953.
45. Ibid, p. 1.
34. Memorandum, from Lowell T. Coggeshall, M.D.,
Chairman of the CMS, to Chairman, CMS RDB, Subject: 46. Army Inspector General Report, “Use of Volunteers in
“Human Experimentation,” 12 March 1953. Chemical Agent Research,” 1975.

35. Memorandum, from Col. R. B. Firehock, General 47. Memorandum, from Frank Knox, Secretary of the
Staff Assistant, to The JAG, U.S. Army, Subject: “Use of Navy, to All Ships and Stations, Subject: “Unauthorized
Volunteers in Research,” 16 April 1953. Medical Experimentation on Service Personnel,” 7 April
1943.
36. Memorandum, from Lt. Gen. L. L. Lemnitzer, General
Staff, Deputy Chief of Staff for Plans and Research, to 48. Department of the Navy, Bureau of Medicine and
Secretary of the Army, Subject: “Use of Human Volunteers Surgery, “Manual of the Medical Department,” Section 4,
in Experimental Research,” 30 March 1953, p. 1. Research Article 1-17, 26 September 1951, p. 2.
Chapter 1—DoD Human Subjects Protection Policy 1944 to the Present 21

49. Ibid, p. 2.

50. Memorandum, from Col. Perry B. Griffith, USAF,


Deputy Assistant for Atomic Energy, USAF, to Lt. Gen. B.
L. Boatner, The Inspector General, Subject: “Use of
Human Volunteers in Experimental Research,” 10 March
1953.

51. Memorandum, For The Record, Attached to


Memorandum, from Col. Irving L. Branch, USAF, Acting
Chief of Staff, AFSWP, to Assistant Secretary of Defense
(Health and Medicine), Subject: “Status of Human
Volunteers in Bio-Medical Experimentation,” 5 March
1954.

52. Department of the Navy, “Manual of the Medical


Department,” 20-8, Change 36, 7 March 1967.

53. Department of the Navy, SecNav Instruction 3900.39,


28 April 1969.

54. DoD Policy Memorandum, 10 June 1993.

55. AR 40-7, Use of Investigational Drugs and Devices in


Humans and the Use of Schedule I Controlled Drug
Substances; AR 40-38, Clinical Investigation Program;
AR 70-25, Use of Volunteers as Subjects of Research;
Secretary of the Navy Instruction 3900.39B, Protection of
Human Subjects; HSETC Instruction 6000.41A, Clinical
Investigation Program; AF Instruction 40-402, Using
Human Subjects in Research, Development, Testing and
Evaluation; AF Instruction 40-403, Clinical Investigation
in Medical Research, Guidance and Procedures; AF Policy
Directive 40-4, Clinical Investigations and Human Use in
Medical Research.
22
CHAPTER TOTAL-BODY & PARTIAL-BODY
2 IRRADIATION STUDIES
TOTAL -B ODY IRRADIATION T REATMENT FOR …doses could be delivered than with previous
C ANCER equipment.”1
These high-energy treatments were initially
Interest in radiation as a treatment for disease unsuccessful. Due to bone marrow depression,
developed within the civilian medical community in patients were unable to tolerate the higher doses of
the early part of this century. The effects of radiation radiation used. Bone marrow, the soft fatty tissue
observed by doctors and researchers provided found in bone cavities, is the factory for red and
valuable information on radiation’s use as a treatment white blood cells and platelets (blood particles that
for different types of cancer. Early radiation research play a major role in blood clotting). Bone marrow
led to the development of two treatment methods depression can lead to potentially fatal complications,
known as total-body irradiation (TBI) and partial- such as anemia and infection.
body irradiation (PBI). Total-body irradiation, also During the 1960s and 1970s, the development of
known as whole-body irradiation, involves the use of bone marrow transfusions led researchers to try TBI
external radiation sources to deliver a relatively and PBI again on radioresistant cancers. Bone
uniform amount of radiation to the entire body. marrow transfusion enabled patients to tolerate the
Partial-body irradiation delivers a relatively uniform higher doses of radiation needed to combat
amount of radiation to a specific part of the body. radioresistant cancers.
In its initial uses, civilian doctors had more
success with TBI in treating radiosensitive cancers
(those that generally respond well to radiation DEPARTMENT OF DEFENSE INTEREST IN TOTAL-
treatments) than in treating radioresistant cancers. BODY I RRADIATION RESEARCH
By the 1940s, therefore, TBI was considered an
acceptable treatment for radiosensitive cancers, such The relationship of the DoD with the civilian
as leukemia and lymphoma. The definition of which cancer research community began in the early 1950s.
types of cancers were radioresistant was changing in The DoD was interested in collecting data on the
the 1950s. Technological advances in equipment by physical and psychological effects of radiation
the late 1950s caused researchers to reconsider TBI as exposure. The DoD sought to (1) predict the
a treatment to reduce the intensity of radioresistant hospitalization requirements and decrease in work
cancers of the lung, breast, colon, and other organs. capacity of soldiers who were exposed to radiation on
These later attempts to treat radioresistant cancers a nuclear battlefield, (2) estimate the manifestations
with TBI were reasonable because new sources could of radiation exposure on workers at nuclear weapons
produce high-energy radiation. The availability of production facilities of the Atomic Energy
high-energy radiation sources (cobalt-60, cesium-137, Commission (AEC), (3) estimate the manifestations
and megavolt x-ray machines) allowed researchers to of radiation exposure on the general population in
treat radioresistant cancers with TBI because “[t]hese the event of a nuclear war.
new teletherapy units allowed high-energy radiation The DoD funded post-treatment data collections
to penetrate deeper into the body without damaging and analyses during five clinical TBI projects
the overlying skin and soft tissues; thus, higher between 1950 and 1972 that have been of recent
23
24 Chapter 2—Total-Body & Partial-Body Irradiation Studies

public interest. The DoD’s interest in these projects “SYSTEMATIC AND CLINICAL EFFECTS OF WHOLE-
was that information could be collected on the B ODY X-I RRADIATION”
biological and psychological effects of TBI. This data
collection included observing and recording the The University of Texas MD Anderson
physical manifestations of post-irradiation syndrome Hospital and Tumor Clinic of Houston
or radiation sickness. Additionally, the DoD was
looking for a biological dosimeter, or marker, to
Background of Total Body Irradiation Research at
enable military doctors to estimate from a simple test
MD Anderson Hospital
(such as a test of body fluids) the radiation dose an
individual received. The studies took place at the
Between 1951 and 1956, the University of Texas
University of Texas MD Anderson Hospital and
MD Anderson Hospital and Tumor Clinic of
Tumor Clinic of Houston in Texas, Baylor University
Houston conducted studies involving TBI. The
College of Medicine in Houston, Texas, the Sloan-
principal investigator was Gilbert Fletcher, M.D.
Kettering Institute for Cancer Research in New York,
Shortly before this research began, during the
the University of Cincinnati College of Medicine
late 1940s, the DoD and the United States Air Force
(UCCM) in Ohio, and the U.S. Naval Hospital in
(USAF) began investigating the possibility of
Bethesda, Maryland. This chapter discusses these five
developing a nuclear-powered aircraft, a program
projects (see table 1).

TABLE 1 CHRONOLOGICAL LISTING OF TOTAL-BODY IRRADIATION/PARTIAL-BODY IRRADIATION STUDIES


DISCUSSED IN THIS CHAPTER

Human Radiation Experiment Number of


Title Location Dates Participants

Systematic and Clinical Effects of University of Texas, 1951-1956 263


Whole-Body X-Irradiation MD Anderson Hospital and
Tumor Clinic, Houston, TX

The Effects of TBI and PBI on Iron Baylor University College of 1952-1964 112
Metabolism and Hematopoiesis Medicine, Houston, TX

The Study of the Post-Irradiation Sloan-Kettering Institute for 1954-1964 34


Syndrome in Humans Cancer Research, New York, NY

Radiation Effects in Man: University of Cincinnati College of 1960-1972 88 *


Manifestations and Therapeutic Efforts Medicine, Cincinnati, OH

Use of Total-Body Radiation in the U.S. Naval Hospital, Bethesda, 1960-1961 17


Treatment of Far-Advanced Bethesda, MD
Malignancies

* “Radiation Effects in Man: Manifestations and Therapeutic Efforts,” DNA 3024F, Report of 1 April 1971 through 31 March 1972, p. 1, states
that 88 patients were irradiated in this program; however, the American College of Radiology and the UCCM Ad Hoc Committee Review reported that
106 patients were referred to the program but 24 dropped out, which indicated 6 fewer patients than listed in the Technical Report.
Chapter 2—Total-Body & Partial-Body Irradiation Studies 25

commonly referred to as the TERMS USED IN THIS CHAPTER


Nuclear Energy for the
Propulsion of Aircraft (NEPA) amino aciduria excretion of amino acids in the urine
project. The Air Force was bone marrow the tissue found in bone cavities, the factory
concerned about the potential for red and white blood cells and platelets
adverse health effects on the
bone marrow depletion/ failure to produce the normal amount of
crew of a nuclear-powered depression/failure blood cells or overproduction of only certain
aircraft, and wanted: blood cells

to determine the effects of carcinoma any malignant tumor arising from cells in the
exposures to ionizing ra- lining membrane of a body organ (includes
diation upon one’s ability most cancers of the lungs, breast, stomach,
to perform simple and skin, and cervix)
complex mental and psy- cobalt-60 a radioactive isotope used in the treatment
chomotor tasks in order to of cancer
predict the effects upon
the crew operating the hematologic of the blood and its diseases
NEPA aircraft.2 irradiate/irradiation to treat by exposing to x-rays, ultraviolet
rays, radium, or some other form of radiant
Therefore, in 1951, the Air Force energy
School of Aviation Medicine palliative providing relief but not cure
(SAM) issued contract AF-18
(600)-926 to MD Anderson platelet cells associated with the process of blood
Hospital, which remained in clotting
effect until 1956. post-irradiation sickness (radiation sickness) sickness produced by
This Air Force contract overexposure to radiation, characterized by
funded post-treatment data nausea, diarrhea, bleeding, loss of hair, and
collection on (1) the effects of increased susceptibility to infection
ionizing radiation, including rad a unit of absorbed dose of ionizing radiation;
documenting the physical acronym for radiation absorbed dose
symptoms of radiation sickness, red blood cells blood cells that carry oxygen to the body
and (2) the effects of radiation on tissues
psychomotor capabilities (the
relationship between mental white blood cells cells important in the body’s defenses
against infection
processes and muscular activities).
World War II 1939-1945, fought between the Allies (Great
Britain, France, the Soviet Union, Canada,
Research Goals and the United States as well as other
nations) and the Axis (Germany, Italy,
Japan, and other countries)
Observational research on
the potential effects of radiation
exposure to aircrews operating a cancer, the researchers attempted to determine the
nuclear-powered aircraft was performed in effects of ionizing radiation exposures on one’s ability
conjunction with MD Anderson Hospital’s ongoing to perform simple and complex mental and
clinical study comparing the value of radiotherapy psychomotor tasks and to develop a biological marker
and chemotherapy for treating generalized cancer. In that would quantify or reveal the level of radiation
addition to investigating TBI as a treatment for exposure an individual had received.3
26 Chapter 2—Total-Body & Partial-Body Irradiation Studies

Patients and Treatments the psychomotor capabilities needed to operate


aircraft.7 Participants for these tests were selected
A total of 263 patients participated in this from the 263 patients receiving TBI treatments for
research. All of the participants were patients at MD cancer. The psychomotor testing was divided into
Anderson Hospital. Patients were assigned to TBI two studies:
treatment levels according to the severity of their
disease.4 The first study was concerned with the ques-
tion of whether a given air dose would have a
greater effect when delivered in a single ex-
posure than when delivered in a series of frac-
Exposure to Total-Body Irradiation tionated exposures. The second study was
organized as a straightforward dose-response
Exposure to TBI as a treatment for cancer was study extending to relatively high exposure
divided into two phases. The first phase comprised levels.8
233 patients exposed to doses ranging from 15 to 200
roentgen (R). The radiation source was a 250 kVp In the first study, participants were adult males in
General Electric Maxitron.5 Patients received either advanced stages of cancer not correctable by surgery
single doses or a series of small repeated doses. This or localized radiation therapy. Ages for this study
segment of the participants was further subdivided ranged between nineteen and seventy-six years.
into three groups. The second phase involved a series Participants in this study had been treated with either
of thirty patients who received single doses of 200 R single or small repeated doses of radiation.9
(see table 2).6 Participants in the second study were adult males
ranging in age from twenty-three to seventy-six and
were in advanced stages of cancer. These participants
Psychomotor Tests had been treated with single doses of radiation only.10
Psychomotor capabilities were tested using three
Psychomotor tests were initiated in 1951 to chart perceptual-motor tasks. These tests evaluated basic
the effects of low-level ionizing radiation on some of skills necessary to operate aircraft and had been used

TABLE 2 EXPOSURE TO TBI AS A TREATMENT FOR CANCER, MD ANDERSON HOSPITAL

Participants Exposure
(Hospital Patients with Cancer) (in Roentgen)

Phase I (233 patients)


Group I 199 15 R to 75 R
Group II 18 100 R
Group III 17 125 R, 150 R, 175 R, 200 R

Phase II (30 patients)


30 200 R (single doses only)

Source: Lowell S. Miller, M. D., Gilbert H. Fletcher, M. D., and Herbert B. Gerstner, M. D., “Systematic and Clinical Effects Induced in 263
Cancer Patients by Whole-Body X-Irradiation with Nominal Air Doses of 15 to 200 R” (USAF Randolph AFB, Texas: Air University School of
Aviation Medicine, May 1957), pp. 16-17. This report provided an unexplained discrepancy regarding the number of participants. The report
indicated that Phase I comprised 233 patients. However, the breakdown into three groups for this phase totaled 234 (i.e., Group I 199, Group II
18, Group III 17).
Chapter 2—Total-Body & Partial-Body Irradiation Studies 27

to select aviation cadets during ACRONYMS USED IN THIS CHAPTER


World War II.11 The tests were
administered to participants ACHRE Advisory Committee on Human Radiation Experiments
before and after receiving ACR American College of Radiology
radiation to measure whether
the treatments would cause AFIP Armed Forces Institute of Pathology
these skills to deteriorate. The AFMPC Armed Forces Medical Policy Council
Air Force SAM Complex
AFSWP Armed Forces Special Weapons Project
Coordination Test required
participants to coordinate DASA Defense Atomic Support Agency
movement of a stick and rudder DoD Department of Defense
bar to match the position of
GAO General Accounting Office
three red lights and three green
lights. The Air Force SAM kVp peak kilovolts
Two-Hand Coordination Test JPMAAW Joint Panel on the Medical Aspects of Atomic Warfare
required participants to operate
two crank handles to keep a NEPA Nuclear Energy for the Propulsion of Aircraft
cursor positioned on a moving PBI partial-body irradiation
target. The Air Force SAM R roentgen; unit of exposure used in measuring ionizing
Rotary Pursuit Test required radiation
participants to follow a rotating
target with the tip of a stylus.12 REM acronym for roentgen equivalent man; a unit of dose,
taking into account the biological effectiveness of the
radiation type

Research Results SAM (Air Force) School of Aviation Medicine


TBI total-body irradiation

The use of TBI as a UCCM University of Cincinnati College of Medicine


treatment for radioresistant USAF United States Air Force
cancer showed some limited
successes. For some patients,
200 R of total-body irradiation produced definite, In the first study, the data collected did not
although temporary, symptomatic relief from their provide any evidence that TBI treatments affected
cancer. In a number of other cases, the researchers psychomotor performance; radiation treatments did
reported additional improvements in patient not alter performance on any of the psychomotor
conditions.13 tests.15 Results for the second study were slightly
The investigators also reported on the physical different. There was no evidence from the Two-Hand
effects (typically referred to as radiation sickness) of Coordination and Rotary Pursuit tests that exposure
TBI treatments. Their report stated: to ionizing radiation affected psychomotor skills.
However, performance on the Complex Coordination
These effects—predominantly nausea, vom- test decreased after radiation treatments. Although
iting, and bone-marrow depression—were this result may have indicated radiation exposure to
practically absent below 100 R. They became have an impact on performance, the investigators
noticeable between 125 R and 175 R, and noted that the decrease in performance could have
developed into complications requiring treat- been an effect of the disease rather than an effect of
ment in 10 percent of the patients at 200 R.14 radiation or a combination of both. Researchers also
28 Chapter 2—Total-Body & Partial-Body Irradiation Studies

noted that the decrease in performance was slight, Research Goals


and because the decrease was so small, the result may
have been of little significance.16 The primary purpose of this investigation was to
define and quantify the therapeutic effects of TBI as a
treatment for cancer. Initially, the therapeutic aspects
“THE EFFECTS OF TBI AND PBI ON IRON and biologic effects of TBI in single doses up to 200 R
METABOLISM AND HEMATOPOIESIS” were the principal objectives of the study. As the
research progressed, the investigators expanded their
Baylor University College of Medicine, attention to include therapeutic effects of lower doses
Houston, Texas of radiation over time. From 1956 (four years into the
project) through the end of the study, the researchers
Background of Total Body Irradiation Research at were not only concerned with the effects of single
Baylor University College of Medicine doses that were well within accepted human
tolerance limits but also with the cumulative effects
From December 1952 until January 1964, of repeated small doses administered over time.18 The
researchers at Baylor University in conjunction with part of the study involving small repeated doses had
the Texas Medical Center and Jefferson Davis the potential to answer some of the questions the
Hospital in Houston conducted TBI research. The DoD had regarding backgrounds of continuous
DoD’s interest in this project was the information radiation in the event of a nuclear war.
collected on the biological and psychological effects In addition to investigating the therapeutic
of TBI. The principal investigator for the project was effects of TBI, researchers at Baylor University sought
Vincent P. Collins, M.D. to establish a predictable relation between radiation
The DoD realized that the use of nuclear exposure and biologic response. More specifically, the
weapons could generate a background of continuous researchers focused on identifying enzyme systems in
radiation in which people would have to live, work, circulating red blood cells to establish a biologic
and fight. Because of this possibility, there was a need marker of radiation exposure.19 Information obtained
to know what “a chronic low dosage of ionizing from this research also had the potential to benefit
radiation would do to immunity, blood coagulation, the DoD in developing a simple enzyme test that
wound healing, infection, nutrition . . . in combat or could determine the amount of radiation an
similar casualties.”17 individual had received. This would assist DoD
In December 1952, a Baylor University project personnel in identifying and treating people
proposal was reviewed and approved by the following following exposure to radiation.
organizations: Armed Forces Special Weapons Project
(AFSWP), Armed Forces Medical Policy Council
(AFMPC), Joint Panel on the Medical Aspects of Patients and Treatment
Atomic Warfare (JPMAAW), and the Armed Forces
Institute of Pathology (AFIP). Three contracts were A total of 112 patients participated in this
issued over the study’s twelve-year period. The first project. All of the participants were adults with
two contracts (DA-49-007-MD-302 and DA-49-007- widespread or advanced cancer. Follow-up continued
MD-428) were issued by AFSWP. As part of a 1959 for as long as the patient’s condition permitted. From
reorganization, AFSWP was redesignated the Defense the beginning of the project until February 1956, the
Atomic Support Agency (DASA), which issued the majority of patients received TBI from conventional
contract (DA-49-146-XZ-032). 250 kVp therapy equipment, and following this
Chapter 2—Total-Body & Partial-Body Irradiation Studies 29

period, researchers used a 2 million electron volt radiation sickness may be avoided by proper health
(MeV) Van de Graaff x-ray generator.20 care management.24 The researchers concluded from
Participants, who received TBI for the treatment these observations that with factual information
of advanced cancer, were divided into three groups. regarding the effects of radiation exposure, normal,
Group I received single exposures of 25 to 250 R. healthy individuals could tolerate even higher
There were seventy-one individuals, or 63 percent of exposures without undue incapacitation.25
the patients, in this group. Group II received The researchers also reported the results of
protracted irradiation (small repeated exposures) supplementary bone marrow studies. Developed first
ranging from 25 to 545 R total exposure over a period in animals, techniques for removal, processing,
ranging from two to sixty-three days (e.g., one patient storage, and reinfusion of bone marrow were quickly
received 545 R total exposure spread over eighteen adopted for use with humans.26 However, despite all
days, or approximately 30 R per day for eighteen the successes and data available from hematologic
days). There were thirty-four individuals, or 31 studies, a definite relationship between the amount of
percent of the patients, in this group. It was expected radiation and biological response was not established,
that studies of this group would result in information and a biological marker was not found.27
that might be useful among military personnel when
occupying a radioactive area. Group III received
repeated courses of treatment over several months or, “T HE STUDY OF THE P OST -I RRADIATION
in some cases, several years. This group consisted of SYNDROME IN HUMANS”
seven individuals, or 6 percent of the patients, who
initially received either single or repeated exposures Sloan-Kettering Institute for Cancer Research
and, after months or years of remission, developed
recurrent symptoms requiring further TBI treatments. Background of Total-Body Irradiation Research at
Exposures ranged between 170 R and 500 R total Sloan-Kettering Institute for Cancer Research
exposure spread over four to forty-two months (e.g.,
one patient initially received 100 R spread over seven From June 1954 until January 1964, researchers
days and twenty-five months later returned to receive at the Sloan-Kettering Institute for Cancer Research
100 R spread over six days).21 in New York conducted TBI research. The principal
investigator was J. J. Nickson, M.D.
The project used TBI as a treatment method for
Research Results cancer. Information was also collected on clinical
observations, hematologic parameters, plasma protein
Although many of the cancer patients referred to distribution, urine excretion, and
the project were terminally ill, positive response to electroencephalograms (electrical activity of the
TBI therapy for some was reflected by decreased node brain).28 Several contracts were issued throughout the
size and decreased drug requirements for pain project. The AFSWP funded the results of the
control.22 “In some instances, response was dramatic; program from 1954 to 1959. AFSWP contracts
a few completely bedridden patients became included DA-49-007-MD-533; DA-49-007-MD-669;
ambulatory and several experienced long-term DA-49-007-MD-910; and DA-49-007-MD-1022. The
remission,” the report stated.23 In addition, the study final contract, DA-49-146-XZ-037, was issued under
of all patients who developed symptoms of radiation DASA in July 1959 and lasted until January 1964.
sickness following therapeutic TBI indicated that, for The project was monitored by the Office of the Army
levels up to 200 R in single or repeated exposures, Surgeon General.
30 Chapter 2—Total-Body & Partial-Body Irradiation Studies

Patients and Treatment “RADIATION E FFECTS IN MAN: MANIFESTATIONS


AND T HERAPEUTIC E FFORTS ”
A total of thirty-four patients participated in this
project. The participants were patients at the Sloan- University of Cincinnati College of Medicine
Kettering Institute for Cancer Research and were
selected because they had widespread cancer that was Background of Total-Body Irradiation Research at the
resistant to medical procedures at the time. Throughout
University of Cincinnati College of Medicine
the ten years of the study, twenty-two patients received
TBI, and twelve received radiation to the head for
The research at the University of Cincinnati
treatment of tumors. The radiation source was a 2 MeV
College of Medicine (UCCM) examined the
Van de Graaff x-ray generator. Exposures ranged from 50
effectiveness of using new, deep-penetrating TBI
to 150 R for TBI and up to 4,000 R for localized cancers.
technology to improve the treatment of patients with
Clinical follow-up continued up to approximately
advanced cancer. During the 1950s and 1960s, the
seventy-five days after exposure to radiation.29 Ages
DoD sought information on the biological and
ranged from nineteen to sixty-three years, with an
clinical features of radiation injury. The DoD funded
average age of forty-seven years. Existing documents
laboratory studies and psychological tests of cancer
identified the participants by initials, types of cancer,
patients after they had received TBI and PBI as
and, in some cases, by age and sex.30
treatment for their disease. The DoD’s initial
objective was to obtain a biological marker of
Research Results radiation exposure. After 1965, the DoD was also
interested in obtaining data on the psychological
Several patients experienced regression of their response to radiation exposure.
disease and changes in the abnormal growth of new Eugene L. Saenger, M.D., a physician in the
tissue.31 The investigators found hematologic Department of Radiology at UCCM who later
changes to be the most consistent biological became principal investigator for the research,
marker of radiation exposure. Investigators noted submitted an unsolicited research application in
that these changes showed variable decreases in September 1958 to the Research and Development
white blood cell counts and platelet counts after Division of the Office of the Army Surgeon
exposure to radiation. In some cases, the General.33 Over the next one and a half years, Army
investigators compared post-irradiation counts Medical Corps officers reviewed the proposal and
with the patient’s own pre-irradiation counts. recommended approval of the contract application.34
Those comparisons led the investigators to By October 1959, DASA began negotiating a
conclude that multiple exposures (e.g., three contract with the University of Cincinnati for the
treatments at 30 R) produced a more severe study of the metabolic changes in humans following
depression of white blood cells and platelets than TBI.35
comparable total dose delivered at one exposure. On 1 January 1960, DASA awarded contract
The researchers also conducted urine studies in an DA-49-146-XZ-029 to the University of
attempt to locate other biological indicators of Cincinnati.36 This contract, with supplements and
radiation exposure. They reported that urinary modifications, remained in effect through February
excretion of creatine, creatinine, and pentose 1964. On 1 June 1964, the second contract (DA-49-
appeared to increase as the radiation dose 146-XZ-315) was awarded and remained active until
increased.32 The investigators did not report any April 1969.37 On 15 June 1969, DASA awarded the
definitive conclusions on the post-irradiation third and final contract, DASA-01-69-C-0131,
syndrome in humans. which remained in effect until March 1972.38 The
Chapter 2—Total-Body & Partial-Body Irradiation Studies 31

project was terminated at the completion of the third infused bone marrow early in the post-irradiation
contract, and the University of Cincinnati declined period, hoping to prevent these problems. In May
to initiate a new contract.39 1963, researchers in this project proposed establishing
facilities for the withdrawal, storage, and reinfusion of
bone marrow.44 By April 1966, a filtration system for
Patients and Treatments the reinfusion of human bone marrow was
completed,45 and by April 1969, success in bone
A total of eighty-eight40 patients from Cincinnati marrow reinfusion was achieved.46 The use of this
General Hospital participated in this project. Patient process immediately after radiation therapy
selection criteria required that only individuals with minimized the characteristic bone marrow depression
proven metastatic or far-advanced cancer be selected associated with higher doses of radiation. The degree
for the studies. In addition, subjects had to be in of illness following reinfusion was significantly
relatively good nutritional status and, in most cases, decreased and hospitalization greatly shortened.47
have normal hematologic values. These criteria No success was achieved in the search for a
remained relatively constant throughout the twelve biological marker for radiation exposure. By 1963, the
years of the study. UCCM researchers also sought researchers concluded that the elevation of amino
patients who had not undergone previous radiation or acids in urine was nonspecific and not solely
chemotherapy, had normal kidney function and new, characteristic of irradiation. The researchers then
abnormal tissue growth that was not radiosensitive, began to investigate breakdown products of
and were without lymphoma or bronchogenic deoxyribonucleic acid (DNA). Deoxycytidine was
cancer.41 one such product that showed elevated levels after
According to a 1972 University of Cincinnati irradiation.48 However, researchers discovered that
review of the project, the majority of the patients the presence of elevated levels of this product in
treated in this study were African-American. Most of urine could have been caused either by radiation or
the patients treated were indigent. Some of the from other sources, such as burns.49 When the study
patients had relatively low intelligence quotients. was discontinued in 1972, the researchers were
The demographic distribution of study participants attempting to develop a means to differentiate
reflected the patient population of the Cincinnati between elevated levels of deoxycytidine created by
General Hospital.42 All patients received either single irradiation and elevated levels of deoxycytidine
or multiple exposures of therapeutic radiation from a created by other sources.
cobalt-60 teletherapy unit. Doses ranged from as low
as 16 rads in the first year of research to as high as
300 rads in the later years. PsychologicalStudies

Psychological studies of the patients in the UCCM


Research Results project began in 1965.50 The DoD’s objective was to
determine the effect of radiation exposure on emotional
UCCM researchers determined that TBI and PBI and intellectual functioning. The tests were designed to
therapies were effective in controlling certain take into account the many complex variables that may
advanced cancers. They reported that the relief influence the measurement of these functions after
effects of radiation treatments compared favorably radiation treatment. The tests included the Reitan Trials
with results using anticancer drugs or chemotherapy.43 Test, Cattell’s 16 Personality Factor Test, Wechsler
Delivery of higher radiation doses caused patients to Depression Rating Scale, Wechsler Adult Intelligence
experience blood problems, which included loss of Scale, and the five-minute verbal content test of
red and white blood cells and platelets. Doctors Gottschalk and Gleser. The researchers found
32 Chapter 2—Total-Body & Partial-Body Irradiation Studies

evidence of a decrease in intellectual functioning Medicine, appointed an Ad Hoc Committee made


immediately after radiation. This effect was up of members of the UCCM faculty to review the
temporary, and functioning improved markedly project. Dr. Grulee asked the committee to review
within three days. Those with higher intelligence the project’s scientific content, methodology, and
quotients showed less of a decrease than those with data treatment.54 The committee’s report, released in
lower intelligence quotients.51 January 1972, indicated that there were no problems
with the project’s scientific content or methodology.
In addition, the committee stated that there was no
UCCM Review Processes evidence that DASA funding was made contingent
on work, ideas, or suggestions proposed by DASA
During its course, the UCCM project came and all information reported to DASA was kept
under intense scrutiny from groups inside the unclassified and publicly available.55
University of Cincinnati and from outside Immediately following the release of the Ad Hoc
organizations (see table 3). Committee report in January 1972, three members of
In November 1971, Senator Mike Gravel of Alaska the UCCM Junior Faculty Association released “A
requested that the American College of Radiology Report to the Campus Community.” This report was
(ACR) evaluate the UCCM project.52 In January 1972, highly critical of the research and urged the
the ACR responded to Senator Gravel’s request. The cancellation of the project.56
ACR reviewed the science, methodology, and design of
the project from a medical point of view to determine if
the project conformed to then-contemporary standards “USE OF TOTAL -BODY RADIATION IN THE
for clinical investigations. The ACR report concluded TREATMENT OF FAR-A DVANCED MALIGNANCIES ”
that the UCCM project was validly conceived, stated,
executed, controlled, and followed up; the process of U.S. Naval Hospital, National Naval Medical
patient selection conformed with sound medical Center, Bethesda, Maryland
practice; and procedures for obtaining patient consent
were valid, thorough, and consistent with National Background of Total Body Irradiation Research at
Institutes of Health recommendations and the practices the U.S. Naval Hospital, Bethesda, Maryland
of most cancer centers.53
Also in November 1971, Clifford Grulee, M.D., Between 1960 and 1961, the United States Navy
Dean of the University of Cincinnati College of sponsored and performed a TBI study at the U.S.

TABLE 3 SCIENTIFIC AND ETHICAL REVIEWS OF THE UCCM PROJECT

Organization Dates

1. UCCM and DoD contract officers 1958-1972 (ongoing throughout


project)

2. American College of Radiology November 1971-January 1972

3. University of Cincinnati College of Medicine Ad Hoc Committee November 1971-January 1972

4. General Accounting Office December 1971-May 1972

5. University of Cincinnati Junior Faculty Association January 1972


Chapter 2—Total-Body & Partial-Body Irradiation Studies 33

Naval Hospital, National Naval Medical Center in patient’s bone marrow did not appear to be affected
Bethesda, Maryland. The military purpose was to by the disease, a portion could be removed for
establish a biological marker for exposure to radiation reinfusion following treatment. These bone marrow
by tracking the excretion of amino acids following reinfusions enabled researchers to safely expose
TBI treatments. The primary researcher for this patients to larger doses of TBI with only temporary
investigation was Chief of Radiology at the U.S. marrow depression.59 All six patients treated with
Naval Hospital, CAPT E. Richard King, Medical small multiple exposures experienced marked relief of
Corps, USN. generalized pain and decreases in the size of cancer
lesions. The results from the single exposure group
were more varied, although four of the eleven
Patients and Treatment experienced some relief from generalized pain and
disease. However, the results did not indicate to the
There were seventeen patients from the U.S. researchers that small repeated exposures were more
Naval Hospital, Bethesda, Maryland, participating in effective in treating cancer than a large single dose
the project. All were hospitalized due to advanced because differences in dose delivery were based on
cancer and “had received conventional radiation each patient’s clinical status.60
therapy or chemotherapy, or both, in addition to In addition to examining TBI as a treatment for
some form of surgery.”57 To administer TBI to the cancer, patients’ urine was collected and studies were
patients, the doctors at the Naval Hospital arranged performed on the urinary excretion of amino acids
to use the cobalt-60 source located at the Naval (such as taurine) following TBI treatments in an
Medical Research Institute, a separate facility located attempt to establish a biological marker for exposure
on the same site as the Naval Hospital. to radiation. Although the results from these tests
Patients were divided into two groups. Each suggested that, at exposure levels of 450 R or greater,
patient in the first group (eleven patients) was urinary excretion of taurine increased, the researchers
treated with a single dose of TBI. Each patient in the reported, “However, there appears to be no direct
second group (six patients) was treated with several correlation between the dose of radiation and the
smaller doses of TBI. For those patients who received amount of taurine excreted.”61 The source of the
single doses of TBI, exposures ranged between 225 R increased taurine was unknown, and the researchers
and 1,500 R. For those patients who received noted the need for further studies to determine that
multiple doses, total exposures ranged between 200 R source.
and 600 R. These multiple exposures were delivered
over a period of time ranging between two and
sixteen days. Five of the six patients in this group SUMMARY
received treatments in increments of 100 R per
treatment, while the sixth patient received TBI continues to be used today. The Advisory
treatments in increments of 25 R. Patients in both Committee on Human Radiation Experiments
groups consisted of men, women, and children.58 (ACHRE) Final Report states:

Since the 1980s, TBI has again been used to


Research Results treat certain widely disseminated, radioresistant
carcinomas at doses as high as 1,575 rads in
conjunction with effective bone marrow trans-
The researchers reported that the results of
plantation, which became routinely available in
treatments with TBI were encouraging. TBI therapy the late 1970s.62
in a dose range of between 100 and 400 R appeared
to offer relatively safe and reasonably effective relief The DoD awarded contracts involving five TBI
therapy for advanced radiosensitive cancers. If the projects between 1950 and 1972 that have been of
34 Chapter 2—Total-Body & Partial-Body Irradiation Studies

recent public interest. All five TBI projects used 6. Ibid, p. 5.


TBI as a treatment method for cancer. The DoD’s
interest in these projects was the information 7. Technical Report, Col. Robert B. Payne, “Effects of
collected on the biological and psychological effects Acute Radiation Exposure on Human Performance,” p. 3.
of TBI. This secondary objective included observing
8. Ibid, p. 4.
and recording the physical manifestations of post-
irradiation syndrome or radiation sickness. 9. Ibid.
Additionally, the researchers were looking for a
biological dosimeter or marker to enable military 10. Ibid, pp. 9 - 10.
doctors to detect, with a simple test (such as a test of
body fluids), the radiation dose an individual 11. Ibid, pp. 4–5.
received.
12. Ibid, p. 4.

13. Technical Report, Lowell S. Miller, Gilbert Fletcher,


N OTES and Herbert B. Gerstner, “Systematic and Clinical Effects
Induced,” p. 7.
(To obtain copies of the following documents, see appendix 2.)
14. Ibid, p. 20.
1. Advisory Committee on Human Radiation
Experiments, Final Report (Washington, D.C.: U.S. 15. Technical Report, Lt. Col. Robert B. Payne, Medical
Government Printing Office, October 1995), p. 370. Service Corps, USAF, “Effects of Ionizing Radiation Upon
Human Psychomotor Skills” (USAF Randolph AFB, Tex.:
2. Project Specifications for “A Study of Intellectual, Air University School of Aviation Medicine, December
Perceptual, and Psychomotor Abilities of Patients 1958), p. 6.
Following Radio-Therapy,” p. 1, attached to
Memorandum, from Lt. Lando Haddock, USAF, to 16. Ibid, p. 9.
Commanding General, Air Materiel Command, Wright-
Patterson Air Force Base, Subject: “Negotiation of Cost 17. Letter, from Lt. Col. Harold F. Hamit, Medical Corps,
Reimbursement Contract,” 19 October 1950. Chief, Surgical Research Branch, Research and
Development Division to James D. McMurrey, M.D.,
3. Research proposal for contract extension, “A Study of Assistant Professor of Surgery, Baylor University College
Intellectual, Perceptual, Psychomotor and Biomedical of Medicine, 17 January 1958.
Status of Patients Following Exposures to Moderate
Quantities of Ionizing Radiation,” 27 January 1954. 18. Progress Report, Vincent P. Collins, M.D., Professor of
Radiology, Baylor University College of Medicine, “A
4. Technical Report, Col. Robert B. Payne, Medical Study of the Effects of Total and Partial Body Radiation on
Service Corps, USAF, “Effects of Acute Radiation Iron Metabolism and Hematopoiesis,” Report of
Exposure on Human Performance” (Brooks Air Force 1 February 1956 to 1 September 1956 (Houston, Tex.:
Base, Tex.: USAF School of Aerospace Medicine Baylor University College of Medicine), p. 1.
Aerospace Medical Division (AFSC), February 1963), p. 3.
19. Progress Report, Vincent P. Collins, M.D., “A Study
5. Technical Report, Lowell S. Miller, M.D., Gilbert of the Effects of Total and Partial Body Radiation on Iron
H. Fletcher, M.D., and Herbert B. Gerstner, M.D., Metabolism and Hematopoiesis,” Report of 1 September
“Systematic and Clinical Effects Induced in 263 Cancer 1955 to 31 January 1956, p. 1.
Patients by Whole-Body X-Irradiation with Nominal
Air Doses of 15 to 200 R” (USAF Randolph AFB, Tex.: 20. Progress Report, Vincent P. Collins, M.D., “A Study
Air University School of Aviation Medicine, May of the Effects of Total and Partial Body Radiation on Iron
1957), p. 2.
Chapter 2—Total-Body & Partial-Body Irradiation Studies 35

Metabolism and Hematopoiesis,” Report of 1 February Astronautics Research Branch, to Col. Hullinghorst,
1956 to 1 September 1956, p. 1. Subject: “Application for Research Contract,”
12 November 1958.
21. Final Report, Vincent P. Collins, M.D., Professor of
Radiology, Baylor University College of Medicine, “The 35. Disposition Form, from Capt. David Lambert, USN,
Effect of Total Body Irradiation on Immunologic Tolerance Deputy Chief of Staff Weapons Effects and Tests, to
of Bone Marrow and Homografts of Other Living Tissue,” Director of Logistics, Subject: “Negotiation of Contract,”
1 February 1963 to 31 January 1964, pp. 2 –4. 29 October 1959.

22. Ibid, p. 6. 36. Contract No. DA-49-146-XZ-029, Contract for:


Research Relating to Study the Phenomenon of Amino-
23. Ibid. Aciduria Following Irradiation, signed 1 March 1960,
effective 1 January 1960; includes seven modifications.
24. Ibid.
37. Contract No. DA-49-146-XZ-315, Contract for:
25. Ibid. Research to Obtain New Information About the
Metabolic Effects of Total Body and Partial Body
26. Ibid, p. 17. Irradiation, signed 5 January 1965, effective 1 June 1964;
includes six modifications.
27. Ibid, p. 20.
38. Contract No. DASA 01-69-C-0131, Contract for:
28. Study Profile, Capt. C. B. Galley, USN, Armed Forces Study of Radiation Effects in Man: Manifestations and
Radiological Research Institute, “Post-Irradiation Therapeutic Efforts, signed 12 November 1969, effective
Syndrome in Man,” 1994. 15 June 1969; includes three modifications and contract
completion statement.
29. Annual Report, James J. Nickson, M.D., and Irvin S.
Glikman, M.D., “The Study of the Post-Irradiation 39. Letter, from Eugene L. Saenger, M.D., to Director,
Syndrome in Man” (New York, N.Y.: Sloan-Kettering Defense Nuclear Agency, 26 April 1972.
Institute for Cancer Research, 1 January 1960 to
31 January 1961). (Estimate given in the text here is 40. Technical Report, Eugene L. Saenger, M.D. et al.,
based on charts at the end of the report.) “Radiation Effects in Man: Manifestations and
Therapeutic Efforts,” Report of 1 April 1971 to 31 March
30. Study Profile, Capt. C. B. Galley, “Post-Irradiation 1972, p. 1. (Although this report states that 88 patients
Syndrome in Man.” were irradiated in this program, the American College of
Radiology and the UCCM Ad Hoc Committee Review
31. Progress Report, James J. Nickson, M.D., and Henry J. reported that 106 patients were referred to the program
Kody, Jr., M.D., “Study of the Post-Irradiation Syndrome but 24 dropped out, which indicates 6 fewer patients than
in Humans,” 1 April 1954 to 31 March 1955, p. 3. listed in the technical report. Letter from Robert W.
McConnell, M.D., President, ACR, to The Honorable
32. Annual Report, James J. Nickson, M.D., and Irvin S. Mike Gravel, 3 January 1972, p. 6. Report, The Ad Hoc
Glikman, M.D., “The Study of Post-Irradiation Syndrome Review Committee, “The Whole Body Radiation Study,”
in Man,” p. 2. January 1972, p. 26.)

33. Application for Research Contract, “Metabolic 41. Technical Report, Eugene L. Saenger, M.D.,
Changes in Humans Following Total Body Radiation,” “Metabolic Changes in Humans Following Total Body
25 September 1958. Irradiation,” Report of 1 November 1961 to 30 April 1963,
p. 3.
34. Memorandum, from Lt. Col. Arthur D. Sullivan,
Medical Service Corps, Assistant Chief, Biophysics and 42. Report, The Ad Hoc Review Committee of the
University of Cincinnati, “The Whole Body Radiation
36 Chapter 2—Total-Body & Partial-Body Irradiation Studies

Study at the University of Cincinnati: A Report to the 53. Letter, from Robert W. McConnell, M.D., President,
Dean of the College of Medicine,” January 1972, p. 28. ACR, to The Honorable Mike Gravel, 3 January 1972,
p. 1.
43. Technical Report, Eugene L. Saenger, M.D. et al.,
“Radiation Effects in Man: Manifestations and 54. Memorandum, from Clifford G. Grulee, Jr., M.D., to
Therapeutic Efforts,” Report of 1 April 1971 to 31 March Members of the Ad Hoc Committee, 12 November 1971.
1972, p. 27.
55. Report, The Ad Hoc Review Committee, “The
44. Technical Report, Eugene L. Saenger, M.D., Whole Body Radiation Study,” January 1972, pp. 44, 46.
“Metabolic Changes in Humans Following Total Body
Irradiation,” Report of 1 November 1961 to 30 April 1963, 56. “A Report to the Campus Community,” UCCM
p. 17. Junior Faculty Association, 25 January 1972.

45. Technical Report, Eugene L. Saenger, M.D., 57. E. Richard King, “Use of Total-Body Radiation in the
“Metabolic Changes in Humans Following Total Body Treatment of Far-Advanced Malignancies,” Journal of the
Irradiation,” Report of 1 May 1966 to 30 April 1967. American Medical Association, 177 (2 September 1961),
p. 88.
46. Technical Report, Eugene L. Saenger, M.D., et al.,
“Radiation Effects in Man: Manifestations and 58. Ibid, pp. 87–88.
Therapeutic Efforts” (Washington, D.C.: Headquarters,
Defense Atomic Support Agency), Report of 1 May 1968 59. Ibid, p. 89.
to 30 April 1969, p. 4.
60. Ibid, pp. 88.
47. Technical Report, Eugene L. Saenger, M.D., et al.,
“Radiation Effects in Man: Manifestations and 61. Ralph R. Cavalier, Milton Van Metre, F.W. Chambers,
Therapeutic Efforts,” Report of 1 April 1971 to 31 March Jr., and E. Richard King, “Taurine Excretion in Humans
1972, p. 27. Treated by Total-Body Radiation,” Journal of Nuclear
Medicine, vol. 1 no. 186 (1960), pp. 187, 190.
48. Technical Report, Eugene L. Saenger, M.D. et al.,
“Metabolic Changes in Humans Following Total-Body 62. Advisory Committee, Final Report, p. 370.
Irradiation,” Report of February 1960 to 30 April 1966,
p. 2.

49. Technical Report, Eugene L. Saenger, M.D., et al.,


“Radiation Effects in Man: Manifestations and
Therapeutic Efforts,” Report of 1 May 1970 to 30 April
1971, p. 50.

50. Report, The Ad Hoc Review Committee, “The


Whole Body Radiation Study,” January 1972, p. 34.

51. Ibid, pp. 36–39.

52. Letter, from Otha W. Linton, Director, Washington


Office, ACR, to The Honorable Mike Gravel,
24 November 1971. (This document is a secondary source
that mentions the date of Senator Gravel’s letter
requesting the ACR to evaluate the UCCM project.
Senator Gravel’s original letter has not been located.)
CHAPTER NASOPHARYNGEAL IRRADIATION
3 THERAPY
BACKGROUND AND OVERVIEW tissue at the entrance to the eustachian tubes to
prevent middle ear obstructions, infections, and
Radium, a radioactive metallic element deafness. By the mid-1920s, Johns Hopkins
discovered in 1898, was introduced into the world of University funded the J. H. Otological Laboratory to
medical therapy soon after its discovery.1 Over time, study deafness in children. Researchers Samuel J.
radium irradiation was used internally and externally Crowe, M.D., and his colleagues stated that
to treat gastrointestinal, genitourinary, and brain nasopharyngeal irradiation with radium was the most
cancers; lymphomas and leukemias; nonmalignant effective treatment for treating certain types of
tumors; goiters; thymus problems; thyroid disorders; middle ear deafness.2 By the late 1920s, Dr. Crowe
acne; scalp ringworm; and birthmarks. Radium was had developed and standardized a radium applicator
also effective in shrinking inflamed tissue. and a recommended treatment regime, which was
Nasopharyngeal irradiation therapy was a medical subsequently adopted by many medical practitioners.3
technique, initially using radon then later radium, to As the use of this and other applicators became
treat patients for hearing impairment caused by widespread, the most common procedure was to place
chronic inflammation of the middle ear (termed otitis the applicators into the nasopharyngeal region for
media). This therapy has also been called radium rod periods that ranged from six to twelve minutes.
therapy. Nasopharyngeal radium irradiation (NRI) Typically, the treatment involved using two radium
was also used during and after World War II in the applicators, each containing 50 milligrams of radium.
military to treat aerotitis media (also called middle A local anesthetic was given to the patient, and the
ear barotrauma), a form of otitis media resulting from applicators were inserted into each nostril (see figure
pressure changes in the middle ear. 2).4 The goal of the treatment was to reduce the
Nasopharyngeal radium therapy involved routing lymphatic tissue at the opening of the eustachian
a radium tipped applicator (see figure 1) through the tubes, allowing the ears to drain. Treatments were
nasal passage and leaving it in place for a specified routinely repeated over a period of months as
time before removal. The civilian use of radium rod determined by tissue response to therapy.
treatment set the precedent for its use in treating Researchers found that excess lymphoid tissue
certain military personnel. Both civilian and military was present in a substantial percentage of children
facilities used this procedure from the late 1940s until with middle ear hearing loss. The best time to treat
the 1960s. this form of hearing deficiency was found to be during
childhood, before recurrent ear infections caused
irreversible damage to the inner ear. By the late
THE DEVELOPMENT OF R ADIUM ROD TREATMENT 1930s, it was standard practice to use NRI for treating
repeated viral and bacterial infections, asthma that
Civilian Research and Implementation occurred with repeated viral infections, recurrent
middle ear infections, sinusitis, and recurrent
In the 1920s, nasopharyngeal irradiation using tonsillitis.5
radium, radon, and x-rays was reported in medical Proponents of radium rod treatment noted
journals as highly effective for shrinking lymphoid several advantages of nasopharyngeal irradiation over
37
38 Chapter 3—Nasopharyngeal Irradiation Therapy

study of nasopharyngeal treatment.


Funded by the National Institutes of
Health (NIH) from 1948 to 1953, this
study concluded that nasopharyngeal
treatments decreased lymphoid tissue
swelling and improved hearing.6 Radium
rod therapy was accepted as the safest
treatment to alleviate otitis media in
both adults and children.

MILITARY USES OF RADIUM ROD


T REATMENT
Figure 1 Profile of the nasopharynx radium applicator
Aircrew Radium Treatment

conventional x-irradiation and surgery. Radium Nasopharyngeal radium treatment was an


therapy could shrink lymphoid tissues in areas effective means of alleviating middle ear problems in
previously inaccessible to surgeons. Over time, both Army Air Forces (AAF) and Navy servicemen.
Dr. Crowe became the leader in the area of The rapid pressurization of the middle ear of aircrews
nasopharyngeal irradiation as a treatment for hearing during aircraft descent occurred because pressurized
loss in children and conducted the first extensive cabins had not yet been developed. When pressure
equalization in the ear could not occur due
to blocked eustachian tubes, aerotitis
media could result. Eustachian tube
blockage was particularly prevalent during
the winter months as a result of upper
respiratory tract infections and recurrent
colds experienced by servicemen stationed
in Europe. Middle ear problems, ranging
from pain to ruptured eardrums, would
sometimes keep personnel grounded for
weeks. In 1944, the AAF Surgeon General
officially adopted nasopharyngeal
treatments with the radium applicator for
AAF servicemen.7
A 1944 journal article by E. P.
Fowler, Jr., M.D., described how he
examined, treated, and collected data on
220 AAF personnel suffering recurrent
barotrauma.8 Dr. Fowler served at an
Army hospital in England during the early
Figure 2 Profile of a human skull depicting the 1940s. He had obtained radon from British
emplacement of a radium applicator for the doctors and treated U.S. servicemen from
nasopharyngeal irradiation procedure 1942 to 1944 using a radon applicator. His
study showed that nasopharyngeal therapy
Chapter 3—Nasopharyngeal Irradiation Therapy 39

was 79 percent successful in TERMS/ACRONYMS USED IN THIS CHAPTER


returning aircrews to duty
without further inflammation of AAF Army Air Forces
the lymphoid tissue.9 ACHRE Advisory Committee on Human Radiation
An AAF report10 about the Experiments
Third Air Force Irradiation Unit
CDC Centers for Disease Control and Prevention
further documented military use
of nasopharyngeal therapy. The DVA Department of Veterans Affairs
report detailed the founding of half-life the time taken for the radioactivity level of a
the unit and its mission, as well substance to reduce to half its original level
as the results and variations in
NIH National Institutes of Health
treatment over the one-year
program. The program was tympanic tubes/rods tubes placed in the ear near the tympanic
conducted at Drew Air Field in membrane to drain fluids
Tampa, Florida, and the doctors
involved in the program traveled to training sites temperate zones. In the article, CAPT Page
around the continental United States to administer Northington, M.C., USN, discussed the problems
treatment. The locations included Gulfport Army associated with rapid pressurization and various
Air Field, Mississippi, Esler Field, Louisiana, treatment methods, as well as barotrauma. He
Barksdale Field, Louisiana, Will Rogers Field, described the issue of ear pressure difficulties as the
Oklahoma, Stuttgart Army Air Field, Arkansas, most common ailment experienced by aviators. After
Alexandria Army Air Field, Louisiana, and Dyersburg treating sixty male naval aviators with the Crowe
Army Air Field, Tennessee. By the end of August radium applicator, Dr. Northington concluded,
1945, 2,289 servicemen had been treated with what “. . . the effectiveness of radium therapy in relieving
were termed “encouraging” results. lymphoid tissue obstruction to the eustachian tubes
Another journal article,11 published in 1945, recommends it as the treatment of choice.”12
detailed the beginning of the AAF nasopharyngeal
irradiation treatment program and the events that led
to the AAF Surgeon General’s approval of Submariner Radium Treatment
nasopharyngeal radium therapy. Nasopharyngeal
irradiation was determined to be easier than using x- During World War II, many U.S. Navy
rays or performing surgery in the field. To evaluate submariner trainees experienced barotrauma during
the results of this one-year program, doctors involved submarine escape training. Recognizing barotrauma
were asked to conduct standard examinations and as an occupational injury for these servicemen,
treatment regimes and to keep records. Servicemen researchers at the Submarine Medical Research
who experienced barotrauma and were stationed in Laboratory in New London, Connecticut, sought
the following units were treated based on medical to perform a “fairly definitive study on the causes,
necessity: 1st Corps at Mitchel Field and Westover effects, prediction, and treatment of the disorder.”13
Field, 8th Corps in England, 15th Corps in northern In 1946, they published their findings of a study
Italy, 12th Air Corps in southern Italy, and 3rd Corps involving more than 6,000 men.14 This research
at Drew Field, Florida. The results showed this was designed to investigate the causes of ear
treatment to be highly effective in returning aircrews pressure problems, predict who would experience
to the field. them, and determine ways to prevent and treat this
In 1946, the Submarine Medical Research ailment. One research method was to compare
Laboratory published an article on the effectiveness different possible treatments after giving subjects a
of nasopharyngeal radium therapy for Navy pilots in pressure test.
40 Chapter 3—Nasopharyngeal Irradiation Therapy

Researchers under the supervision of principal Department of Defense (DoD) and the Department
investigators Henry L. Haines, M.D., and J. Donald of Veterans Affairs (VA) are reviewing and analyzing
Harris, Ph.D., collected data on 6,149 young, healthy, these data to determine appropriate actions.
male submariner trainees. The patients were divided
into six groups: five treatment groups and one control
group. The treatments were designed to assist the DISCONTINUATION OF R ADIUM R OD T HERAPY
submarine trainees in accommodating changes during
a pressure test without developing barotrauma. The Centers for Disease Control and Prevention
These treatments were: (CDC) estimate that between 8,000 and 20,000 U.S.
military servicemen were treated with
• Psychological treatment (assurance that the nasopharyngeal irradiation.19 As discussed previously,
ears would heal without extraordinary approximately 8,000 AAF aviators, naval aviators,
intervention; the use of music and chewing and submariners participated in nasopharyngeal
gum was also studied) irradiation studies. The CDC also estimates that
• Symptomatic treatment with nosedrops from 500,000 to 2 million people may have been
(application of a solution of 0.25 percent treated with nasopharyngeal irradiation from 1940 to
neosynephrine in saline solution) the mid-1960s.20
• X-ray treatment The emergence of pressurized aircraft cabins and
• Dental treatment (for those identified with a the resulting substantial decrease of barotrauma as
dental occlusion which may have impacted well as the advent of effective new medical
on the eustachian tube) treatments, such as tympanic tubes and antibiotics,
• Radium treatment.15 led the Air Force and Navy to discontinue the
practice of nasopharyngeal irradiation therapy by the
The sixth group, the control group, received no early 1960s. The new treatments were easier to
treatment. administer and more effective than nasopharyngeal
Of the 6,149 submariner trainees involved in the irradiation. In addition, in the 1950s and 1960s,
study, 26.9 percent ( approximately 1,600) developed medical literature began to report concern that
aerotitis media. A total of 732 of the approximately thyroid cancer might occur from head and neck
1,600 were treated with radium therapy,16 with x-rays and from nasopharyngeal radiation therapy.21
treatment being effective in more than 90 percent of
the cases.17 Other therapeutic measures used in the
study were not as effective as radium. The x-ray R ETROSPECTIVE S TUDIES
treatment was discontinued early in the study. The
five test participants showed swelling and discomfort
not experienced by those receiving the radium rod In the 1980s, two retrospective studies were
treatment, and there were administrative problems conducted regarding the effects of nasopharyngeal
arranging the treatments, which had to be performed irradiation on children. Increased cancer risks in
out of the area.18 other populations exposed to ionizing radiation and
On 30 April 1996, the Navy found Dr. Haines’ the availability of data on children treated with NRI
original log book, which details the 1944 - 1945 indicated that this would be an important population
aerotitis media experiment involving submariners at to study. However, the two studies were inconclusive
the Submarine Medical Research Laboratory and regarding the potential excess cancer risks for treated
Submarine Base, New London, Connecticut. The log children.
book contains detailed study data and the names of The smaller of the two studies was conducted by
the approximately 1,600 participants. The Dale P. Sandler, Ph.D., and her colleagues from Johns
Chapter 3—Nasopharyngeal Irradiation Therapy 41

Hopkins University in Maryland.22 Health data were CURRENT FOCUS ON NASOPHARYNGEAL T HERAPY
gathered in 1982 in a follow-up survey of 904 people
who had received radium rod therapy as children to Recent interest in the possible adverse health
treat hearing difficulties between 1943 and 1960. effects of nasopharyngeal radium therapy led to an
Researchers compared this group to a matched examination of the past use of nasopharyngeal radium
control group of 2,021 children with similar medical therapy within the military and civilian medical
problems who had not received radium rod therapy. communities. Civilian and Government officials
The researchers concluded that the risk for all head have conducted several reviews evaluating the
and neck cancers combined was higher among treatment and its potential adverse health effects, and
persons who had received the treatment than among members of the public have voiced their concerns.
persons who had not. However, the findings were The Senate Subcommittee on Clean Air and
based on small numbers of cancers and were Nuclear Regulation conducted a hearing in August
statistically significant only after all categories of 1994. Chaired by Senator Joseph Lieberman of
head and neck cancers were combined. Connecticut, the hearing participants discussed the
In 1995, Dr. Sandler stated that the results past use of nasopharyngeal irradiation in military and
obtained in her study suggest a small excess risk of civilian practice, possible negative health effects of
head and neck cancer in patients receiving NRI but these treatments on adults and children, and the
that because of the small numbers of cases involved, feasibility of additional studies on the health risks
interpretation was difficult.23 related to radium rod therapy. Testimony at the
A larger study was conducted in The Netherlands hearing indicated that military use of nasopharyngeal
by Peter G. Verduijn, M.D. and his associates. In that radium therapy was within the accepted medical
study, 2,542 children who had been treated with practices of the day. However, panel members
nasopharyngeal irradiation were compared with 2,381 testified that independent studies investigating long-
unexposed children who had also been treated for term health risks associated with this treatment were
hearing loss. The researchers reviewed medical inconclusive.28 As a result of the hearing, the VA
records and followed up on patients from five clinics agreed to conduct a pilot study researching the
in The Netherlands in a 1989 retrospective study of feasibility of an epidemiological study to determine if
the excess cancer risk to children treated with service members who received this treatment in the
nasopharyngeal irradiation.24 No brain cancers were past were now at greater risk for head and neck
observed in the treated population; three were cancers. The CDC agreed to conduct a workshop on
observed in the controls. Thus, this study did not find the issue for both medical specialists and the public.
an excess of head and neck cancer.25 Dr. Verduijn The VA’s pilot study in 1995 researched the
summarized the findings of his study by concluding, feasibility of an epidemiologic study on veterans who
“. . . the present study has found no excess of cancer had received nasopharyngeal irradiation treatments
mortality at any site associated with radium exposure to study the occurrence of disease in this population.
by the Crowe and Baylor therapy. Specifically, the This study determined that there was virtually no
finding of Sandler et al. of an excess of head and neck primary documentation of such treatments for
cancer was not found in this study group.”26 veterans who probably received this treatment.
Due to recent concerns about health risks associated Occasionally, veterans’ medical records showed a
with nasopharyngeal radium therapy, the Johns Hopkins secondary entry, such as a sick call entry, that
University Department of Epidemiology has continued mentioned a radium treatment had been received,
the follow-up study originally conducted by but no treatment time or delivered dose was recorded.
Dr. Sandler.27 Dr. Verduijn is also conducting a follow- An epidemiologic study of veterans, therefore, would
on study of The Netherlands children. be difficult.29
42 Chapter 3—Nasopharyngeal Irradiation Therapy

The CDC conducted its workshop, included the history of the procedure, the doses of
“Nasopharyngeal Radium Irradiation,” on radium used, potential dangers associated with the
27 - 28 September 1995. It was hosted by the Yale treatment, the possibility of resulting health effects,
University School of Medicine and covered such and physician evaluation and care of patients with a
topics as historical medical practices and knowledge, history of NRI. Discussion panel members included
previous and ongoing epidemiologic studies, estimates representatives from the CDC, Yale University
of the scope and number of people treated, and Medical Center, and the VA. To obtain a videotape
possible actions for the future. Participants at the of the conference from the CDC, call
workshop were representatives from the U.S. Senate, 1-800-418-7246.
the Johns Hopkins School of Medicine, the
Radiation Epidemiology Branch of the National
Cancer Institute, the National Institute of SUMMARY
Environmental Health Sciences, the Department of
the Navy, the DoD, various university medical Nasopharyngeal irradiation was a common
centers, and concerned citizens. General comments medical practice from the 1940s to the mid-1960s to
were that the risk to the treated populations was not treat otitis media. Until the 1960, medical texts
substantial and, due to the lack of identifying data recommended radium rod therapy as a viable
and treatment documentation and the relatively treatment for shrinking lymphoid tissue. Such
small number of military personnel treated, it would treatments were used by both civilian and military
probably be difficult to conduct a meaningful physicians. During World War II, the AAF and Navy
epidemiological study.30 found NRI treatments particularly effective in
In addition, President Clinton’s Advisory treating barotrauma caused by rapid pressure changes
Committee on Human Radiation Experiments incurred by servicemen. These treatments allowed
(ACHRE) reviewed studies in the medical thousands of American aircrews and submariners to
community from the 1940s to the present, the remain in service and avoid recurrent health
evolution of nasopharyngeal irradiation therapy, and problems due to barotrauma.
current data on the potential health risks concerned
with such treatments. The ACHRE Final Report
states that although risk estimates to date contain N OTES
considerable uncertainty, the committee did not
recommend notification or medical follow-up of (To obtain copies of the following documents, see appendix 2.)
children or adults exposed to this treatment.31
In response to recommendations made by panel 1. Edith H. Quimby, “The Background of Radium
members of the September 1995 CDC workshop, the Therapy in the United States 1906 - 1956,” American
CDC, the DoD, and the VA cosponsored a Journal of Roentgenology, vol. 75, no. 3 (1956), p. 443.
videoconference on current medical issues associated
with the past use of NRI. On 5 September 1996, the 2. Samuel J. Crowe, M.D., “Irradiation of the
Nasopharynx,” Annals of Otology, Rhinology, and
videoconference was broadcast live via satellite to
Laryngology, vol. 55, no. 1 (1946), p. 781.
county extension offices, schools, medical
institutions, universities, all VA hospitals, and some 3. Curtis F. Burnam, M.D., “Irradiation Treatment of
local and regional cable television stations. The Hyperplastic Lymphoid Tissue,” Laryngoscope, vol. 50
videoconference was intended as both a public health (1940), pp. 663 - 670.
outreach effort for the CDC and as a continuing
education opportunity for physicians to learn the 4. Testimony, James Smith, Ph.D., Chief of the
proper means of evaluating and treating individuals Radiation Studies Branch of the National Center for
who report receiving NRI. Primary discussion points Environmental Health, Centers for Disease Control and
Chapter 3—Nasopharyngeal Irradiation Therapy 43

Prevention, Before the Senate Subcommittee on Clean 15. Henry L. Haines and J. Donald Harris, “Aerotitis
Air and Nuclear Regulation, Senate Committee on Media in Submariners,” Annals of Otology, Rhinology, and
Environment and Public Works, 29 August 1994, p. 1. Laryngology, vol. 55 (1946), pp. 352 - 353.

5. Donald F. Proctor, Leroy M. Polvogt, and Samuel J. 16. H. L. Haines and J. D. Harris, “Aerotitis Media in
Crowe, “Irradiation of Lymphoid Tissue in Diseases of the Submariners, Interval Report No. 1,” 18 February 1946,
Upper Respiratory Tract,” Bulletin, Johns Hopkins Hospital, pp. 25, 27.
vol. 83 (1948), pp. 383 - 428.
17. Ibid, p. 2.
6. Testimony, James Smith, Before the Senate
Subcommittee on Clean Air and Nuclear Regulation, 18. Ibid, p. 52, and Henry L. Haines and J. Donald Harris,
29 August 1994, pp. 3 - 4; Samuel J. Crowe, “Irradiation of “Aerotitis Media in Submariners,” Annals of Otology,
the Nasopharynx,” Annals of Otology, Rhinology, and Rhinology, and Laryngology, vol. 55 (1946), p. 352.
Laryngology, vol. 55 (1946), pp. 779 - 788; W. G. Hardy
and J. E. Boordley, “Observations from a Controlled Study 19. Summary Report and Executive Summary, “The Public
on the Effect of Nasopharyngeal Irradiation in a Group of Health Response to Nasopharyngeal Radium Irradiation:
School Age Children,” Annals of Otology, Rhinology, and A Workshop, Centers for Disease Control and
Laryngology, vol. 62, no. 3 (September 1954), p. 825. Prevention,” 27 - 28 September 1995, p. 6.

7. “The Use of Radium in the Aerotitis Control Program 20. CDC, Morbidity and Mortality Weekly Report.
of the Army Air Forces: A Combined Report by the 29 March 1996, p. 255.
Officers Participating,” Annals of Otology, Rhinology, and
Laryngology, vol. 54 (1945), pp. 650, 654. 21. Testimony, Dr. James Smith before the Senate
Subcommittee on Clean Air and Nuclear Regulation,
8. E. P. Fowler, Jr., “Use of Radon to Prevent Otitis 29 August 1994, pp. 4 - 5.
Media Due to Hyperplasia of Lymphoid Tissue and
Barotrauma (Aero-Otitis),” Archives of Otolaryngology, 22. Dale P. Sandler et al., “Neoplasms Following
vol. 40 (1944), pp. 402 - 405. Childhood Radium Irradiation of the Nasopharynx,”
Journal of the National Cancer Institute, vol. 68 (1982),
9. Ibid, p. 405. pp. 3 - 8.

10. Jerome J. Glauber, John N. Smith, and Donald B. 23. Summary Report and Executive Summary, “The
Earl, Report of the Third Air Force Irradiation Unit, Public Health Response to Nasopharyngeal Radium
31 August 1945. Irradiation: A Workshop, Centers for Disease Control and
Prevention,” 27 - 28 September 1995, p. 2.
11. “The Use of Radium in the Aerotitis Control
Program,” Annals of Otology, Rhinology, and Laryngology, 24. Peter G. Verduijn, M.D., et al., “Mortality After
1945, pp. 650 - 660. Nasopharyngeal Irradiation,” Annals of Otology, Rhinology,
and Laryngology, vol. 98 (1989), p. 839 - 844.
12. Capt. Page Northington, M.D., USN, “Radium
Therapy in Aerotitis Media,” US Naval Medical Bulletin, 25. Ibid, p. 843.
1946, p. 1567.
26. Ibid.
13. H. L. Haines and J. D. Harris, “Aerotitis Media in
Submariners, Interval Report No. 1 on Bureau of Medicine 27. Advisory Committee on Human Radiation
and Surgery Research Division Project X-434 (Sub. No. Experiments, Final Report (Washington, D.C.: U.S.
90): Aerotitis Media Among Submariners—Prevention Government Printing Office, October 1995), p. 354.
and Treatment, Section A,” Bureau of Medicine and
Surgery, 18 February 1946, p. 7. 28. Testimony, Dr. James Smith, Before the Senate
Subcommittee on Clean Air and Nuclear Regulation,
14. Ibid, p. 1. 29 August 1994, pp. 1, 5.
44 Chapter 3—Nasopharyngeal Irradiation Therapy

29. Summary Report and Executive Summary, “The


Public Health Response to Nasopharyngeal Radium
Irradiation: A Workshop, Centers for Disease Control and
Prevention,” 27 - 28 September 1995, p. 9.

30. Ibid.

31. Advisory Committee, Final Report, p. 843.


CHAPTER
IODINE-131 STUDY
4 CONDUCTED BY THE ARCTIC
AEROMEDICAL LABORATORY
I NTRODUCTION weather exposure on human physiology. The
importance of this type of research was recognized
In 1947,1 the Air Force School of Aviation when, in June 1942, the Japanese attacked Dutch
Medicine established the Arctic Aeromedical Harbor, Attu, and Kiska in the Aleutian Islands of
Laboratory (AAL) at Ladd Air Force Base near Alaska—then a U.S. territory.
Fairbanks, Alaska. The laboratory was created to In the 1950s, increasing tensions between the
study environmentally related hardships affecting United States and the Soviet Union escalated the
military personnel living and working in the Arctic. potential for active military operations in Alaska and
AAL research and development projects addressed Canada. The United States increased its military
preventive medicine, dietary requirements, presence in Alaska to offset the threat from the
emergency survival procedures and equipment, and nearby Soviet mainland. Additionally, hostilities in
protective flight clothing.2 Due to public concerns Korea, which also involved U.S. forces, warranted
over Native Alaskan participation, this chapter improvements in both equipment and procedures for
focuses on one particular study, “Thyroid Activity in severe cold weather operations.
Men Exposed to Cold.” This study included the use of The potential for conflict demanded U.S.
a radioisotope tracer to assess the role of the thyroid preparedness for operations in challenging
gland in human acclimatization to cold. environments, and a better understanding of the
effects of the harsh climate on troop activities
became more important. Until 1967, the AAL made
B ACKGROUND investigations of such effects easier.

Construction of Ladd Army Airfield began in


1938 near Fairbanks, Alaska. Ladd Field, which “T HYROID ACTIVITY IN MEN EXPOSED TO COLD”
became operational in 1940, was intended as a
bulwark against growing Japanese ambitions in the An important research objective of the AAL was
Pacific region. During World War II, the airfield also to study the effects of cold stress on human
served as the transfer point for aircraft being flown to physiology. Researchers collected extensive data on
the Soviet Union under the Lend-Lease Program. the diet, physiology, and living habits of Native
Ladd Field was designated the home of the Army Air Alaskan men and women living in the Arctic,
Corps’ Cold Weather Experimentation Station. It specifically, the coastal Eskimos of Point Lay and
was from this station that the AAL later evolved. Wainwright, the inland Eskimos of Anaktuvuk Pass,
During and after World War II, increasing and the Athapascan Indians of Fort Yukon and
military operations in severely cold climates Arctic Village. Most of these Native Alaskans resided
necessitated research on protective clothing, survival in tents or log-sod or moss dwellings and survived by
and emergency techniques, and the effects of cold hunting and gathering. Therefore, they were

45
46 Chapter 4—Iodine-131 Study Conducted by the Arctic Aeromedical Laboratory

TERMS/ACRONYMS USED IN THIS CHAPTER any, the thyroid gland served


in human acclimatization to
AAL Arctic Aeromedical Laboratory, established by the cold and to determine if the
Air Force School of Aviation Medicine, located at thyroid activity of Native
Ladd Air Force Base near Fairbanks, Alaska Alaskans was responsible for
their apparent adaptation to
AEC Atomic Energy Commission [predecessor to the
Department of Energy] Arctic conditions. The
thyroid gland was chosen as
basal metabolism the amount of energy needed to maintain essential the focal point of the AAL’s
basic body functions research because previous
endemic a disease or disorder constantly present in a studies had demonstrated:
particular region or specific group of people (1) increased thyroid activity
goiter enlargement of the thyroid gland, due to lack of in animals correlated with
sufficient iodine in the diet severe exposure to cold,
(2) involvement of the
half-life the time for the activity of a substance to decay to
thyroid in human
half its original level
acclimatization to cold,3 and
iodine-131 (I-131) a radioactive isotope of iodine; used in diagnosis of (3) elevated basal metabolism
thyroid disorders and the treatment of toxic goiter in Native Alaskans.4 Iodine-
and thyroid carcinoma; I-131 has a half-life of eight 131 (I-131) was the tracer of
days
choice for examining the
isotope one of two or more atoms with the same atomic thyroid because of its natural
number but with different atomic weights. (The tendency to concentrate
nuclei of isotopes have the same number of there.
protons but different numbers of neutrons. Isotopes Eighty-five5 Eskimos and
usually have very nearly the same chemical
seventeen Athapascan
properties but somewhat different physical
properties.) Indians participated in this
study. A control group of
microcurie a unit of radioactivity. One one-millionth curie, or servicemen who were not
the quantity of radioactive material in which the Native Alaskans was made up
number of disintegrations is 3.7 x 104 per second
of six U.S. Army servicemen,
uptake the absorption of a nutrient, chemical (including whose regular activities
radioactive material), and medicine by an organ or involved exposure to cold,
tissue and thirteen Air Force
thyroid (gland) an organ of the endocrine system; the thyroid servicemen, who usually
secretes hormones that control body metabolism worked indoors.6 Participants
tracer a small quantity of radioactive substance were all healthy, “normal”
introduced into the body so that its distribution, individuals.7
processing, and elimination can be followed by During the study, which
using a radiation detector lasted from August 1955 to
February 1957, a total of 2008
tracer doses of I-131 were
constantly engaged in outdoor activities that administered to examine the levels of I-131 in blood,
involved considerable exposure to cold. thyroid, urine, and saliva samples.9 For some subjects,
The AAL’s study, “Thyroid Activity in Men fasting blood samples were taken to analyze serum
Exposed to Cold,” sought to uncover what role, if cholesterol and protein-bound I-131.10 The study also
Chapter 4—Iodine-131 Study Conducted by the Arctic Aeromedical Laboratory 47

involved clinical examinations and in some cases, played a significant role in human acclimatization to
detailed assessments of iodine intake, basal cold. However, over time, improvements in blood
metabolism, and environmental exposure. analysis techniques enabled other researchers to
The standard administration for radioiodine demonstrate that there is a relation between the
tracer studies of the time, as authorized by the thyroid and acclimatization to cold.16
Atomic Energy Commission (AEC), was fifty In retrospect, concerns were raised about the
microcuries.11 Although individual administrations possible vulnerability of the Native Alaskan
were kept as close to fifty microcuries as possible, due participants in the study, particularly because few of
to the long transport of the I-131 from Oak Ridge, the Native Alaskan subjects spoke English and there
Tennessee, and the radioisotope’s short half-life, were language barriers for interpreting some of the
administration generally ranged from eighteen to procedures (e.g., Native Alaskan languages do not
sixty-five microcuries. In one case, nine microcuries have a word for “radiation.”) The AAL Director of
were administered.12 Overall, sixty-eight Native Research at the time of the study, Kaare Rodahl,
Alaskans from Wainwright, Point Lay, Fort Yukon, M.D., maintained that every care was taken to work
and Point Hope received a single tracer dose of I-131 through village elders, medical services were provided
during the study. Twenty-two Native Alaskans and all to the Native Alaskans, and they were given the
nineteen servicemen received two doses of I-131; a chance to refuse to participate. In addition,
group of twelve Anaktuvuk Pass Eskimos and Arctic Dr. Rodahl stated that the radioactive tracer used in
Village Indians participated in three facets of the these studies was, in his opinion, “a harmless medical
study and received three doses of I-131 tracer.13 substance that posed no risk to the subjects due to the
Evaluation of thyroid function indicated small amount of radiation involved.”17
abnormally high and rapid I-131 uptakes in the Although I-131 has now been replaced for
Anaktuvuk Pass Eskimos and the Arctic Village clinical usage by a shorter lived radioisotope, I-123,
Indians. This result was associated with low iodine the doses used in the study were within the standard
intake and a high incidence of thyroid enlargement doses of the time.18 I-131 was the only radioactive
and, therefore, was attributed to endemic goiter tracer readily available for use in the 1950s when the
rather than an indication of the effect of cold AAL thyroid function study was conducted.19
exposure on thyroid function.14 To address congressional and Native Alaskan
Generally, data yielded no results of statistical concerns about this study, the Institute of Medicine
significance, and researchers concluded that on the (IOM) of the National Research Council established
basis of the data: a committee to evaluate these studies and determine
if any follow-up needs to be provided. In its report,
. . . the thyroid does not play any significant the IOM wrote:
role in human acclimatization to the arctic [sic]
environment when the cold stress is no greater “After examining the records, analyzing the
than what is normally encountered by soldiers health effects and talking with research sub-
engaged in usual arctic [sic] service or by Alas- jects as well as researchers, the Committee
kan Eskimos or Indians in the course of their concludes that the probability of physical harm
normal life or activities.15 to the AAL study subjects is negligible, and
thus that the subjects were not harmed. From
an ethical perspective, the Committee con-
SUMMARY cludes that aspects of the AAL study, espe-
cially the informed consent process, were
The results of the study, “Thyroid Activity in flawed even by 1950s standards and thus the
Alaska Natives who participated and, to a
Men Exposed to Cold,” did not support the findings
lesser extent, the military subjects were
of earlier studies, which indicated that the thyroid wronged.”20
48 Chapter 4—Iodine-131 Study Conducted by the Arctic Aeromedical Laboratory

N OTES 12. Arctic Aeromedical Laboratory, “Thyroid Activity in


Men,” p. 3; National Research Council, The Arctic
(To obtain copies of the following documents, see appendix 2.) Aeromedical Laboratory’s Thyroid Functions Study, p. 12.

1. This date is based on Air Force historical documents. 13. National Research Council, The Arctic Aeromedical
A date of 1951 is given by the National Research Council, Laboratory’s Thyroid Functions Study, p. 36.
Institute of Medicine, Arctic Aeromedical Laboratory’s
Thyroid Functions Study: A Radiological Risk and Ethical 14. Arctic Aeromedical Laboratory, “Thyroid Activity in
Analysis (Washington, D.C.: National Academy Press, Men,” p. 82.
1996), p. 2.
15. Ibid, pp. 80–81.
2. “History of the Arctic Aeromedical Laboratory,”
pp. v, 24 (with Air Force Memorandum 22 June 94). 16. As cited in National Research Council, The Arctic
Aeromedical Laboratory’s Thyroid Functions Study, pp. 21, 76.
3. As cited in Arctic Aeromedical Laboratory, “Thyroid
Activity in Men Exposed to Cold,” Technical Report 17. Arctic Aeromedical Laboratory, “Thyroid Activity in
57–36, p. 1. Men,” p. 85.

4. Statement of Dr. Chester Pierce Before the Advisory 18. National Research Council, The Arctic Aeromedical
Committee on Human Research Experiments, 16 March Laboratory’s Thyroid Functions Study, pp. 12, 79.
1995, p. 4.
19. Ibid, p. 2.
5. The text of the AAL Technical Report 57-36 (pp. 3,
81) states “...19 whites, 84 Eskimos and 17 Indians.” 20. National Research Council, The Arctic Aeromedical
However, the number of Eskimos who participated in the Laboratory’s Thyroid Functions Study, p. 5
study was reported as 85 in several of the Technical
Report’s tables.

6. Arctic Aeromedical Laboratory, “Thyroid Activity in


Men,” p. 2.

7. Ibid, p. 6.

8. The text of the AAL Technical Report 57-36 (pp. 3,


81) states, “A total of 200 tracer experiments was made
in...” The number of doses received per participant
indicates only 186 doses of I-131 were used.

9. Arctic Aeromedical Laboratory, “Thyroid Activity in


Men,” p. 3–5.

10. Ibid, p. 5.

11. National Research Council, Institute of Medicine,


The Arctic Aeromedical Laboratory’s Thyroid Functions
Study: A Radiological Risk and Ethical Analysis (Washington,
D.C.: National Academy Press, 1996), p. 12.
CHAPTER
INTENTIONAL ATMOSPHERIC
5 RELEASES OF RADIOACTIVE
MATERIAL
The United States emerged from World War II Another intentional atmospheric release of
with a nuclear monopoly—a position it held for only radiation occurred during the Atomic Energy
four years. The Soviet Union conducted its first Commission’s (AEC) radioactive lanthanum (RaLa)
atmospheric nuclear weapons test in August 1949. program conducted at Los Alamos Scientific
On 23 September 1949, President Truman Laboratory (LASL). The RaLa program was a series
announced that the Soviets possessed a nuclear bomb of implosion tests critical to the development and
and were undertaking a large nuclear weapon improvement of the plutonium bomb.
development program. This development highlighted
two intelligence and weapons development
requirements for the national security infrastructure: G REEN RUN
(1) the long-range detection of radiological materials
to monitor the Soviet Union’s nuclear weapons The Hanford Site
development program and (2) an increased need for
developing the United States’ nuclear arsenal. The Manhattan Project was the code name for
Earlier in 1947, General Dwight D. Eisenhower, scientific research that was conducted to build an
Army Chief of Staff, assigned the Army Air Forces atomic bomb during World War II. In 1943,
(AAF) the mission of long-range detection of Soviet Manhattan Project officials selected a site near
nuclear tests. The AAF was responsible for worldwide Richland, Washington, to produce plutonium, an
detection of atomic explosions; the collection, element used in nuclear weapons. This site, known as
analysis, and evaluation of required scientific data; the Hanford Nuclear Reservation, became the world’s
and the appropriate dissemination of the resulting first plutonium factory (see map 1). Hanford
intelligence.1 The long-range detection of production facilities expanded between 1947 and
radioactive releases was an integral component in the 1953 to meet increased Cold War demands for
development of methods to collect data on foreign nuclear weapons materials.2 Management
countries’ production of radioactive materials and responsibility for the Hanford Nuclear Reservation
their atmospheric nuclear weapons tests. transferred from the Manhattan Project to the AEC
One means of developing and testing methods for in 1947.
the long-range detection of radioactive material was
to conduct an atmospheric release test. The
Department of Defense participated in one such What Was Green Run?
atmospheric release, which was in December 1949 in
Washington State. The test was known as “Green After irradiation in one of Hanford’s four nuclear
Run.” The premise of Green Run was that aerial reactors, nuclear fuel was normally stored for 83 to
monitoring and sampling of a radioactive cloud, even 101 days before it was processed to extract
at great distances from its release point, could provide plutonium.3 This cooling period allowed many
evidence of the presence of radioactive materials. radioactive materials with short half-lives to decay.
49
50 Chapter 5—Intentional Atmospheric Releases of Radioactive Material

MAP 1 THE HANFORD ENGINEER WORKS


Chapter 5—Intentional Atmospheric Releases of Radioactive Material 51

To release sufficient radioactive ACRONYMS USED IN THIS CHAPTER


material into the environment
to conduct the long-range AAF Army Air Forces
monitoring test, fuel that had ACHRE Advisory Committee on Human Radiation Experiments
been cooled for only sixteen
AEC Atomic Energy Commission [predecessor of the
days (i.e., “green” material) was
Department of Energy]
used. The use of the green
material resulted in a much DoD Department of Defense
greater release of HEDR Hanford Environmental Dose Reconstruction Project
iodine-131 (I-131) and
HID Health Instrument Division of the General Electric
xenon-133 (Xe-133) into the
Company
environment than would have
occurred under normal LASL Los Alamos Scientific Laboratory, now called the Los
production conditions. Alamos National Laboratory (LANL)
RaLa radioactive lanthanum
TSP Technical Steering Panel
Preparations for Green Run
USAF United States Air Force
On 25 October 1949, Xe-133 xenon, the 54th element on the periodic chart; produced
representatives of the Air Force, artificially in nuclear reactors and nuclear explosions;
the AEC, and the General has a half-life of 5.7 days
Electric Company (Hanford’s
postwar contractor) agreed on a
plan for a larger-than-routine • Conditions allowing the radioactive
release of radioactive material from Hanford for the emissions to stay aloft long enough to be
Green Run long-range detection test.4 The report measured.6
“Dissolving of Twenty Day Metal at Hanford” states that
Hanford officials planned to release into the Because weather conditions were critical to the
environment approximately 4,000 curies of test, the Air Force’s Air Weather Service expanded
I-131 and 7,900 curies of Xe-133.5 existing weather forecasting and observation
The Health Instrument Division (HID) of the stations.7 The Air Force also added a forecaster to the
General Electric Company, responsible for public Spokane Air Force Base weather station specifically
health at the Hanford Nuclear Reservation in 1949, for the Green Run test.8
required the following weather conditions before
initiating Green Run:
The Green Run Event
• Local inversion of air (a layer of cold air near
the ground was required to help prevent Unusually inclement weather in late November
released radioactive materials from reaching 1949 caused a one-week postponement of the test.
the ground before they were well diluted) Test planners prepared to begin the Green Run
• No rain or fog, which would prevent the release on the night of 2 December. An updated
airborne radiological data collection efforts forecast predicted acceptable weather conditions for
• Wind speed at less than 15 miles per hour at 2 December, that were expected to continue for the
200 feet twelve-hour period needed to complete the release.9
• West to southwest winds to facilitate airborne Originally, the Air Force had recommended
radiological data collection effort beginning the release between 1:00 a.m. and
52 Chapter 5—Intentional Atmospheric Releases of Radioactive Material

TERMS USED IN THIS CHAPTER 3:00 a.m. on 3 December so


that the bulk of the
containment the policy of attempting to prevent the radioactivity would be released
influence of an opposing nation or after dawn. This would make
political system from spreading the task of tracking the
radiation easier. However, a
curie a unit of radioactivity
local temperature inversion
gamma radiation electromagnetic, rather than charged (one of the weather conditions
particle, radiation; highly penetrating required by test planners to
“green” period the period before decay, or cooling, of initiate the test) was predicted
radioactive materials in nuclear fuel to end on the morning of
half-life the time for the activity of a substance 3 December. The Air Force
to decay to half its original level and HID managers
compromised on a start time of
iodine-131 (I-131) a radioactive isotope of iodine; used in
8:00 p.m. on 2 December.10
diagnosis of thyroid disorders and the
The Green Run release
treatment of toxic goiter and thyroid
carcinoma; I-131 has a half-life of eight began at 8:00 p.m. on
days 2 December 1949. The
material was released from a
Los Alamos Human A research team that investigated Los
spare dissolver in Hanford’s “T”
Studies Project Team Alamos’ involvement in human
plant (see figure 1). Air
radiationexperiments
scrubbers were intentionally
Manhattan Project the top-secret project during WWII to deactivated for Green Run to
build an atomic bomb; Los Alamos was maximize the radioactive
selected as the bomb laboratory site;
material released into the
Hanford, Wash. and Oak Ridge, Tenn.
atmosphere.
were selected as the sites for
plutonium production The Air Force used air-
sampling aircraft mounted with
nuclear weapon a weapon where energy results from multiple radiological measuring
the fission of heavy elements or fusion
devices to monitor radiation
of hydrogen isotopes
levels in the Hanford area.11
point source radioactive material that is manually Air sampling began near dawn
placed in a known spot; usually used on the morning of 3 December
for calibration or measurement and continued until the
purposes and re-covered after the test
afternoon of the same day.12
Weather conditions
RaLa radioactive lanthanum during the release were
scrubbers a device designed to prevent the unstable. Several unpredicted
release of radioactive particles changes in the weather
occurred during the twelve-
World War II 1939-1945, fought between the Allies
hour release. Increased wind
(Great Britain, France, the Soviet
Union, Canada, and the United States speeds decreased the strength
as well as other nations) and the Axis of the inversion, and a shift in
(Germany, Italy, Japan, and other the wind direction half-way
countries) through the release affected the
Chapter 5—Intentional Atmospheric Releases of Radioactive Material 53

Figure 1 Hanford’s “T” plant, from where the Green Run material was released

distribution of radiation and the amount that was In addition to the Air Force cloud sampling,
deposited locally.13 ground-based static and mobile radiological
monitoring devices were used to measure radiation
levels. The overall pattern of deposited I-131 on
Measuring Contamination vegetation after the Green Run release “extended in
an elongated shape about 40 miles wide and 200
Estimates vary about the actual quantity of miles long lying northeast and southwest of the”
radioactive material released into the environment as Hanford site.15
a result of the Green Run release. The report Approximately 2,500 vegetation samples were
“Dissolving of Twenty Day Metal at Hanford” taken from October through December 1949, about
estimates that up to 7,780 curies of I-131 (almost one-half taken after the Green Run release.16
twice the original estimated amount) and 20,000 According to the Advisory Committee on Human
curies of Xe-133 (approximately two and one-half Radiation Experiments (ACHRE) study on the
times the original estimated amount) were released.14 Green Run release, “Measurements of radioactivity
Reasons for the discrepancies in the estimated on vegetation produced readings that, while
amounts before and after the test are unknown. temporary, were as much as 400 times the then-
54 Chapter 5—Intentional Atmospheric Releases of Radioactive Material

‘permissible permanent concentration’ on vegetation River water, drinking water, sediment, fish, and other
thought to cause injury to livestock.”17 Animal aquatic life.
specimens collected from the Hanford reservation The TSP disbanded on 31 December 1995.
“received thyroid irradiation varying from tolerance Additional information on the Green Run and
to 80 times tolerance daily.”18 other Hanford releases can be obtained from the
The HID’s December 1949 activity report stated: Hanford Health Information Network (HHIN),
2400 Smith Tower, 506 Second Avenue, Seattle,
Widespread contamination by I-131 occurred Washington 98104, Telephone: (206) 223-7660.
as a result of a specifically requested dissolv-
ing at short cooling time. The prediction that
this could be accomplished once with negli-
T HE R A L A P ROGRAM
gible risk to personnel was supported by the
experimental observations. However, the re-
sultant activity came close enough to signifi- The Los Alamos Scientific Laboratory Site
cant levels, and its distribution differed enough
from simple meteorological predictions that the The RaLa program was developed at LASL in
H.I. Divisions [sic] would resist a proposed New Mexico. LASL’s main research goal was to
repetition of the test.”19 study weapon implosion dynamics. The Air Force
involvement in the RaLa tests was limited to flying
a specially equipped B-17 aircraft to track the
Access to Further Information on Green Run location and level of contamination in the
atmosphere resulting from three of the 254 RaLa
The Technical Steering Panel (TSP) of the tests. The purpose of these air sampling tests was to
Hanford Environmental Dose Reconstruction examine the military’s capability to track
(HEDR) Project was established in 1987 to address radiological material released into the
public health concerns. The TSP’s main objective environment.
was to estimate radiation doses to Hanford residents.
Although Green Run was not a major emphasis of
the TSP, data related to Green Run were The RaLa Studies
incorporated into this dose reconstruction effort.
Radiological monitoring data routinely collected From September 1944 to March 1962, 254
for the Hanford area were vital tools used by the TSP implosion experiments involving various amounts
experts to evaluate the quantity of radioactive of high explosives and radioactive lanthanum were
material released into the environment as a result of conducted at LASL. The entire RaLa program was
day-to-day plant operations. The HEDR project conducted in Technical Area 10 in Bayo Canyon
scientists estimated that 98 percent of the radiation (see map 2).
doses received by Hanford area residents were the For these implosion tests, a lanthanum-140
result of I-131. According to the TSP, “[t]he Green (La-140) source was placed inside a high-explosive
Run release contributed about 2.3 percent of the total test assembly. La-140 was used primarily because its
I-131 released [from the Hanford Reservation] from short half-life of forty hours ensured short-lived
1944 through 1951.”20 contamination of the test site. Gamma radiation
Measurements of radioactive materials vented to from the La-140 provided information on the
the atmosphere and released to soils and the progression of the implosion process. No nuclear
Columbia River began with the start-up of Hanford bombs were detonated during the RaLa program.
facilities in 1944. Environmental studies expanded to According to the Los Alamos Human Studies
include measurements of radioactive materials in the Project Team, the Atmospheric Physics Laboratory
air, ground, vegetation, food, wildlife, Columbia of the Air Force Cambridge Research Laboratory
Chapter 5—Intentional Atmospheric Releases of Radioactive Material 55

MAP 2 LOS ALAMOS SITE


56 Chapter 5—Intentional Atmospheric Releases of Radioactive Material

took advantage of three of the RaLa events to test Access to Further Information on RaLa
radiation detection equipment. A calibration effort
was conducted after the last tracking flight. In January 1994, the Human Studies Project
The three atmospheric tracking tests were Team was established to collect information on Los
conducted in March and April 1950. The purposes Alamos National Laboratory participation in
of the atmospheric tracking portion of the RaLa human radiation experimentation and the RaLa
tests were: program. None of the RaLa data collected
contained information suggesting that any human
first to track a radiological gaseous cloud as experimentation of any kind was planned or
long as possible, second, to study the rate performed in conjunction with any RaLa tests. For
at which the ionization produced by the ra- more information on the RaLa studies, contact the
dioactive matter decreases and diffuses, and
Department of Energy (see appendix 2 for
finally to analyze the “fallout” of radioactive
substances from the cloud.21
information).

The radiological data sampling equipment was


mounted in the nose of a B-17 aircraft flown out of N OTES
Kirtland Air Force Base, New Mexico.22 The
(To obtain copies of the following documents, see appendix 2.)
atmospheric sampling tests were divided into three
segments: measurement of background 1. Memorandum, from General Dwight D. Eisenhower,
conductivity, the tracking of the radioactive cloud, Army Chief of Staff, to Commanding General, AAF,
and measurement and mapping of the radioactive Subject “Long Range Detection of Atomic Explosions,”
“fallout.”23 16 September 1947.
To track the progress of the radiological cloud,
the B-17 attempted to fly through the cloud’s 2. U.S. Department of Energy, Human Radiation
center and collect radiological data.24 The aircraft Experiments: The Department of Energy Roadmap to the Story
continued to track the course of the cloud for one and the Records (Oak Ridge, Tenn.: Office of Scientific and
and one-half to two hours for each of the three Technical Information, 1995), p. 76.
tests. During the 29 March 1950 test, the cloud
3. H. J. Paas and W. Singlevich, Radioactive
was tracked as far away as Waltrous, New Mexico, Contamination in the Environs of the Hanford Works for the
approximately seventy miles from the Bayo Period October, November, December 1949 (Hanford
Canyon test site.25 The second tracking test was Works, Wash.: General Electric Co., 2 March 1950), p. 3.
canceled before completion because the
radioactive cloud drifted over restricted airspace at 4. Memorandum, from Chief of Staff, to Commander,
Los Alamos. During the third test on 6 April 1950, Military Air Transport Service, Subject: “Detection of
the cloud was only visible for a few minutes, Stack Effluents,” 10 November 1949.
making it difficult for the aircraft to fly routes
similar to the first test. The tracking lasted two 5. Lt. W. E. Harlan, D. E. Jenne, and J. W. Healy,
Dissolving of Twenty Day Metal at Hanford (Hanford Works,
hours.26 In July 1950, a B-17 flew over an
Wash.: General Electric Co. Nucleonics Department,
uncovered point source of RaLa to calibrate the 1 May 1950), p. 7.
onboard instruments. After the flyover, the RaLa
container was closed and returned to LASL. No 6. Ibid, pp. 5–6.
radioactive material was released into the
environment during this calibration effort. 7. Ibid, p. 8.
Chapter 5—Intentional Atmospheric Releases of Radioactive Material 57

8. Ibid. 25. Ibid, pp. 9, 12.

9. Ibid, p. 18. 26. Ibid, pp. 12–14.

10. Ibid, p. 7.

11. Ibid, pp. 12–13.

12. Ibid, p. 46.

13. Ibid, pp. 20–25.

14. Ibid, pp. 26–28.

15. H. J. Paas and W. Singlevich, Radioactive


Contamination, p. 3; H. M. Parker, Health Instruments
Divisions Report for Month of December 1949 (Hanford
Works, Wash.: Health Instruments Division, General
Electric Co., 6 January 1950), p. 19.

16. H. J. Paas and W. Singlevich, Radioactive


Contamination, p. 13.

17. Advisory Committee on Human Radiation


Experiments, Final Report (Washington, D.C.: U. S.
Government Printing Office, October 1995), p. 511.

18. Lt. W. E. Harlan, D. E. Jenne, and J. W. Healy,


Dissolving Twenty Day Metal, p. 3.

19. H. M. Parker, Health Instruments Divisions Report, p. 3.

20. Technical Steering Panel of the Hanford Dose


Reconstruction Project, “The Green Run,” Fact Sheet
#12, p. 4.

21. Samuel C. Coroniti, Report on the Atmospheric


Electrical Conductivity Tests Conducted in Vicinity of Los
Alamos Scientific Laboratories, New Mexico (Cambridge,
Mass.: Atmospheric Physics Laboratory, Geophysical
Research Directorate, Air Force Cambridge Research
Laboratories, 26 May 1950), p. 1.

22. Ibid, pp. 3, 7.

23. Ibid, p. 3.

24. Ibid, p. 4.
58
CHAPTER
RADIOLOGICAL WARFARE
6
I NTRODUCTION RECONSIDERATION OF RADIOLOGICAL WARFARE

During World War II, scientists explored military After World War II, the United States began an
uses of radiological materials. The ability to atomic bomb testing program. One test involved an
manufacture radioactive materials had already been atomic weapon detonated underwater at Bikini Atoll,
developed. Scientists began to explore the feasibility Pacific Proving Ground, Marshall Islands. This test,
of dispersing radioactive material over a land area to known as Shot BAKER, was conducted in July 1946
deny its use to the enemy. Discussions included using as part of Operation CROSSROADS. An atomic
such radiological weapons to destroy crops, poison weapon was suspended ninety feet beneath a ship
water supplies, or force the enemy to abandon a anchored in the midst of a target fleet.2 The test
critical facility. weapon had the same power as the bomb dropped at
Radiological warfare involves: Nagasaki (yield equal to
21 kilotons of TNT). “The detonation caused the
the use of radioactive substances to produce fleet to be bathed in radioactive water spray and
personnel casualties or to deny the enemy full radioactive debris from the lagoon bottom.”3 Shot
use of terrain or installations due to the physi- BAKER resulted in widespread contamination of the
ological damage which will result from contin- target fleet and consequently renewed interest in the
ued occupation of the area.1
idea of radiological warfare.
Joseph G. Hamilton, M.D., one of the leading
The dispersal of radiological agents does not involve
civilian scientists studying radiological warfare, wrote
an atomic bomb but rather uses conventional
a memorandum to the Army in December 1946
explosives to disperse radioactive material over a
discussing not only how much damage radiological
given area.
warfare could do but also the need for a greater
The Allies knew that Germany had a fledgling
understanding of how the United States could
atomic weapons development program and that it
combat the effects of radiological weapons.
might also be considering a radiological warfare
Dr. Hamilton wrote:
program. Therefore, the United States developed
contingency plans for a response to German use of I strongly feel that the best protection that this
such weapons. However, allied efforts quickly nation can secure against the possibilities of
crippled the German atomic
bomb effort, and the threat of ACRONYMS USED IN THIS CHAPTER
their use of any radiological
warfare program ceased. As the ACHRE Advisory Committee on Human Radiation Experiments
U.S. atomic bomb program AEC Atomic Energy Commission
progressed from theory to fact, the DoD Department of Defense
United States’ interest in
radiological weapons decreased. TNT trinitrotoluene (a high explosive, used for blasting)

59
60 Chapter 6—Radiological Warfare

TERMS USED IN THIS CHAPTER radioactive agents being


employed as a military
tool by some foreign
attenuation lessen in severity, value, amount, intensity,
power is a thorough
etc.; weaken
evaluation and under-
atoll a ring-shaped coral island nearly or standing of the full poten-
completely surrounding a lagoon tiality of such an agent.4
curie a unit of radioactivity
There were those who
Dugway Proving Ground Army Chemical Corps facility in the Utah argued that radiological
desert warfare could be a more
half-life the time for the activity of a substance to humane form of warfare. It
decay to half its original level could effectively contaminate
isotope atoms of an element with the same number an area without necessarily
of protons but different numbers of neutrons causing immediate death. The
radioactivity level of the
kilotons a thousand tons; the energy of a nuclear weapon and the amount of
explosion that is equivalent to the explosive
time spent in the
power of 1,000 tons of TNT
contaminated area would
Manhattan Project the top-secret project during WWII to build determine the possibility of
an atomic bomb; Los Alamos was selected injury or death. The idea of
as the bomb laboratory site; Hanford, Wash. using radiological warfare
and Oak Ridge, Tenn. were selected as the
weapons to deny an enemy use
sites for plutonium production
of an area by contamination
nuclear fission the splitting of the nuclei of atoms into two was discussed within the
fragments of approximately equal mass military community in the
accompanied by conversion of part of the later months of 1946 and into
mass into energy: the principle of the atomic
1947. The interest in
bomb
radiological warfare became a
point source radioactive material that is manually placed starting point for the
in a known spot; usually used for calibration establishment of programs and
or measurement purposes and re-covered panels.5
after the test
tantalum a rare corrosion-resistant, metallic chemical
element used to make nuclear reactors, THE JOINT RADIOLOGICAL
aircraft, and missile parts, etc.
WARFARE STUDY PANEL
shot test
weathering the effects of weather (wind, rain, etc.) on the In May 1948, the Atomic
residual radioactive material after its initial Energy Commission (AEC) and
dispersal the Department of Defense
(DoD) created a joint study
World War II 1939-1945, fought between the Allies (Great
Britain, France, the Soviet Union, Canada, panel chaired by W.A. Noyes, a
and the United States as well as other chemist from the University of
nations) and the Axis (Germany, Italy, Japan Rochester. The panel, called
and other countries) the Noyes Panel, included DoD
and AEC officials as well as
Chapter 6—Radiological Warfare 61

non-Government experts. The panel’s purposes were protection and undue dissipation of radioactive
to evaluate the feasibility of an offensive radiological materials where serious problems might arise.”11
warfare program and to establish an understanding of
how to defend against a radiological attack. The
panel met six times between May 1948 and R ADIOLOGICAL A GENT SELECTION
November 1950.
At the panel’s first meeting on 23 May 1948, During the radiological warfare testing, scientists
panel members recommended that the study be were researching a variety of radioactive elements for
broken down into three categories: medical and toxicity levels to determine their feasibility as
biological research on the effects of radiation and radiological warfare agents. One 1947 memorandum
radioactive materials conducted by the Army discussed the criteria for radiological agent selection:
Chemical Corps Toxicity Laboratory at The
University of Chicago, chemistry studies on the • Toxicity by inhalation
production of radioactive materials for use in • Toxicity by application to the body or to
radiological warfare carried out mainly by the AEC, clothing
and military uses and dissemination of possible • Rapidity of action [how fast it affects area or
radiological warfare munitions conducted mainly by personnel]
the Chemical Corps.6 • Persistency [how long it remains a danger]
• Stability of the radioactive element [half-life]
• Penetrability of protective devices
THE ARMY CHEMICAL CORPS TEST SAFETY PANEL • Availability in required quantities.12

Concurrent with the Noyes Panel, the Army The elements that met the above criteria included
Chemical Corps established a Test Safety Panel in radiological agents with half-lives that ranged from
May 1949 to review the test designs of radiological seconds to centuries. It was generally thought that the
warfare tests and their impact on the safety of the military operations would benefit most from a
local civilian population.7 The panel, chaired by radioactive element that had a half-life between several
Joseph Hamilton, M.D., consisted of prominent weeks and one year. If the element had too short a half-
Government and civilian physicians and physicists. life, it would no longer be sufficiently active by the time
The panel reviewed Chemical Corps proposals it reached the test site or the battlefield. An excessively
for radiological warfare tests at Dugway Proving long half-life would cause long-term area denial, which
Ground. During the review of the Dugway testing would keep U.S. troops from entering a battlefield they
program, the Test Safety Panel investigated might need to use or cross later. The selection processes
possible dangers, such as contamination to water would enable scientists and researchers to locate the best
supply, food, crops, and animal population.8 The elements to use for radiological warfare munitions.
Chemical Corps was responsible for the safety of
civilian and military personnel working at Dugway
Proving Ground.9 Under Dr. Hamilton’s leadership, THE T EST PROGRAMS
the panel examined and discussed safety concerns,
eventually accepting the test program with the Oak Ridge Tests
understanding that the first two tests would be
subject to review for radiological safety before any While the majority of the radiological warfare
further tests were allowed.10 field testing was conducted at Dugway Proving
On 15 September 1949, a Test Safety Panel report Ground in Utah, the first three field tests were
stated, “The Panel was favorably impressed by the conducted at Oak Ridge, Tennessee. In 1948, Oak
careful consideration given to the manifold problems of Ridge Scientific Laboratory (ORSL) scientists tested
62 Chapter 6—Radiological Warfare

radioactive lanthanum and radioactive tantalum. tantalum, a grid pattern of more than 250 tantalum
They also researched the feasibility of zirconium and wires was placed over a rectangular plot of land.
columbium as radiological warfare agents. Measurements of radioactive intensity were taken at
Radioactive lanthanum was placed at designated certain points in the grid, and the wires were
locations in a field. Measurements were taken at removed. These tests left no residual contamination
varying distances from the source and then the in the environment.14
sources were removed from the field; the sources left
no residual radiation in the environment.13 The first
test involved three radioactive sources of Dugway Tests
approximately 1,280, 100, and 20 curies of
lanthanum. The second test involved only the 1,280- A radiological munition field testing program
curie source. In a third test involving radioactive began at Dugway Proving Ground in Utah in
October 1949 and
continued until 1952. Field
tests used only small
amounts of radioactive
material so that radiation
detection devices could map
the dispersal pattern. There
was no human
experimentation associated
with the radiological
warfare munition testing
program.
Design efforts originally
focused on using an
explosive force to distribute
the radiological agent. Later
in the program’s
development, the designs
focused on a munition that
would release grooved
spheres capable of more
efficiently scattering the
material. Radioactive
tantalum was used because
of its availability. In total,
approximately 13,690 curies
of radioactive tantalum
were released onto the
ground in the form of dust,
small particles, and pellets
during the Dugway testing.
In contrast, radiological
Radiological warfare weapons test target area at Dugway Proving warfare would have required
Ground, Utah millions of curies per square
Chapter 6—Radiological Warfare 63

mile to achieve its military purpose.15 Toward the end weathering on the radioactive tantalum. The
of the program in 1952, there were plans to test a radiological material, tantalum-182, was
100,000-curie device, but the program was severely activated to a level of 480 curies.18
curtailed, and the test of this prototype weapon did
not take place. • Field Test 288 occurred on 6 August 1950. It
was a drop test of a single 2,000-pound
radiological bomb, E59R2, filled with
Munition Tests radioactive tantalum particles. The objective
was to determine the effect of the type of
Eighteen field tests were conducted at Dugway explosive used in the 2,000-pound radiological
Proving Ground by the Army Chemical Corps. Two bomb, E59R1, on the dispersion of radioactive
of these examined the ability to decontaminate an tantalum particles over large areas and to assess
area that had already been contaminated by previous the radiation field produced, the airborne cloud
field tests, and another field test examined the generated, and the effect of weathering on the
attenuation effects of various building materials (such contamination. The radioactive tantalum was
as cinder block and plywood) on radiation levels. activated to a level of 480 curies. The test was
This test used a transient point source, leaving no intended to be an airburst; however, due to
residual radioactivity in the environment. A total of mechanical malfunction, the bomb exploded
sixty-four munitions were used for all the tests. on impact.19
The following is a list of field tests beginning in
October 1949 and ending in September 1952 (also • On 11 August 1950, Field Test 293 was
see table 1). conducted. It was a static test of four shaped-
charge sections of radiological bomb, E59,
• The first radiological warfare munition test filled with radioactive tantalum particles.
was conducted on 22 October 1949. The The objective was to determine the effect of
objective was to study how a radiological shaping the explosive charge used in the
contaminant spreads when dispersed by a bomb on the dispersion of radioactive
bomb. A 2,000-pound radiological bomb tantalum particles and to assess the radiation
containing 260 curies of tantalum-182 was field produced. Each of the four bomb
detonated.16 sections was loaded with 26 curies of
radioactive tantalum, for a total of 104
• A second munition test (Field Test 276) was curies.20
conducted on 30 November 1949. Its
objective was the same as the first, but this • Field Test 289 was conducted on 5 September
time the 2,000-pound radiological bomb 1950. It was an airburst test of a single
contained 1,506 curies of tantalum-182.17 radiological bomb, E65, filled with
radioactive tantalum particles. The test
• Field Test 287 was an airburst test of a single objective was to determine the effect of the
2,000-pound radiological bomb, E59R1, filled type of explosive used in the bomb on the
with radioactive tantalum particles. It was dispersion of radioactive tantalum particles
conducted on 4 August 1950. The objective and to assess the field of radiation produced
of this test was to determine the effect of the by the dispersal. The 2,000-pound bomb
type of explosive used on the dispersion of contained approximately 930 curies.21
radioactive tantalum particles over large areas
and to assess the radiation field produced, the • Field Test 290, conducted on 7 September
airborne cloud generated, and the effect of 1950, involved an airburst test of a single
64 Chapter 6—Radiological Warfare

TABLE 1 RADIOLOGICAL WARFARE MUNITION TESTS CONDUCTED AT DUGWAY PROVING GROUND,


UTAH, 1949 - 1952
# of Radiological Approx.
Field Test Date(s) Test Designation Type of Test Munitions Agent Used Curie Total

22 October 1949 None given airburst 1 tantalum-182 260

30 November 1949 Field Test 276 airburst 1 tantalum-182 1,506


(90% wire, 10% particles)

4 August 1950 Field Test 287 airburst 1 tantalum-182 480

6 August 1950 Field Test 288 groundburst 1 tantalum-182 480

11 August 1950 Field Test 293 static 4 tantalum particles 104

5 September 1950 Field Test 289 airburst 1 tantalum particles 930

7 September 1950 Field Test 290 airburst 1 tantalum particles 3,900

13 September 1950 Field Test 292 static 15 tantalum oxide particles, 14


tantalum chloride dust,
agent RA

29 May 1951 Field Test 619 static 4 tantalum dust pellets 308

3-4 November 1951 Field Test 620 airburst 9 tantalum dust pellets 131

7 November 1951 Field Test 623 airburst 1 tantalum dust pellets 612

8 November 1951 Field Test 624 airburst 1 tantalum dust pellets 756

20 May 1952 Field Test static 4 tantalum dust pellets 1,405


RW 1-52 (compressed)

23-27 May 1952 Field Test airburst 16 99% tantalum dust, 640
RW 2-52 1% molybdenum sulfide

23 September 1952 Field Test static 4 tantalum pellets 2,164


RW 1-53

2,000-pound radiological bomb, E65R2, with generated, the effect of weathering on


a water-cooled jacket, filled with radioactive contamination, and the effect of a water-
tantalum particles. The test objective was to cooled jacket for the bomb in relation to the
determine the effect of the explosive type on above factors. The curie level was 3,900.22
the dispersion of the radioactive tantalum
particles over large areas and to assess the • Field Test 292, conducted on 13 September
radiation field produced, the airborne cloud 1950, involved static tests of experimental
Chapter 6—Radiological Warfare 65

radiological dust generators, E66R2 and compressed radioactive tantalum dust pellets.
E66R3, filled with radioactive tantalum The objective of the test was to determine
oxide, radioactive tantalum chloride, and the effect of varying the explosive and
radioactive agent RA (an agent not specified shaping the charge on the range and
in the report). The objective was to uniformity of dispersion of the pellets of
determine the feasibility of dispersing, as compressed radioactive tantalum dust. The
ground contamination over a small area, bomb contained 612 curies.26
radioactive tantalum oxide particles,
radioactive tantalum chloride dust, and • Field Test 624 was held on 8 November 1951.
radioactive agent RA by thermal generation. It was an airburst test of a 1,000-pound
The objective was also to assess the radiation radiological bomb, E-83, filled with
field produced and the airborne cloud compressed radioactive tantalum dust pellets.
generated. During this test, fifteen munitions The objective was the same as Field Test 623.
were used and approximately 14 curies were The bomb contained 756 curies.27
emitted into the environment.23
• Field Test RW 1-52, on 20 May 1952,
• Field Test 619 was conducted on 29 May involved the static test of four segments of
1951. It was a static test of four full-diameter full-diameter sectional munitions. The
sectional munitions, E65 type, filled with objectives were to determine the effect of
compressed radioactive tantalum dust pellets. shaping the explosive charge of the modified
The test’s objective was to determine the radiological bomb on the dispersion of
effect of shaping the explosive charge of the compressed pellets of radioactive tantalum
radiological bomb on the dispersion of the dust and to assess the radiation fields
pellets. Each munition contained 77 curies, produced. The activity of the radioactive
for a total of 308 curies.24 tantalum in the munitions ranged from 275
to 404 curies, for a total of 1,405 curies.28
• Field Test 620 took place on 3 - 4 November
1951. It was an airburst test of nine spherical • Field Test RW 2-52 took place 23 - 27 May
radiological munitions, E78R2 and E78R3. 1952. It was an airburst test of spherical
These munitions were filled with aerial pellet radiological munitions containing radioactive
disseminators filled with radioactive tantalum tantalum. The objectives were to assess the
dust, which burst at varying altitudes. In radiation fields produced by individual
addition, three inert munitions containing no spherical munitions filled with a radioactive
radiological material were dropped for agent when airburst at various altitudes and
practice. The objective was to establish the to determine the effect of weathering on the
“area of responsibility” of these two types of ground contamination. Sixteen active
individual munitions and to assess the munitions were used in this field test. Before
radiation field produced. The nine munitions this test, six inert simulate munitions were
were filled with radiological material dropped on 21 May 1952 to test the altitude
activated to a level between 8.5 and 17.3 at which they opened. The total activities of
curies each, for a total of 131 curies for the the radioactive tantalum in the spheres were
test.25 calculated to be 38.9 to 40 curies, for a total
of 640 curies.29
• Field Test 623 occurred on 7 November 1951.
It was an airburst test of a 1,000-pound • Field Test RW 1-53 was conducted on
radiological bomb, E-83, filled with 23 September 1952. It was a static test of full-
66 Chapter 6—Radiological Warfare

diameter sections of a radiological munition. troops) that were radiologically contaminated


The objectives were to determine the effect of and to test the feasibility of decontamination
shaping the explosive charge of one 1,000- of construction equipment used in
pound radiological bomb, E83 type, on the contaminated areas.31
dispersion and breakup of the agent and to
determine the extent and intensity of the field • Field Test 311 was conducted to test the
radiation produced. The four functioning effect of various types of construction on the
munitions contained a level of between 359 intensity field produced by a radioactive
and 626 curies, for a total of 2,164 curies.30 tantalum source. A point source of
radiological material was used; no residual
radiological material was released into the
Decontamination and Construction Studies environment. There were three tests, on
26 July, 31 August, and 1 September 1950, to
In addition to the munition studies, two determine the effectiveness of several types of
decontamination studies and one building common construction techniques as a shield
construction study were conducted during the years to radiation exposure from a point source of
of the Dugway radiological warfare testing (see radioactive tantalum-182.32
table 2). This latter test examined the attenuation
effects of various building materials, such as cinder • Field Test RW 5-52 was conducted on
block and plywood, on radiation levels. 4 - 10 June 1952. It dealt with radiological
warfare decontamination and land
• Field Test 291, in August 1950, was designed reclamation studies. No radiological material
to study gross decontamination of radioactive was released into the environment as a result
tantalum dispersed by a single radiological of this field test. The objectives were to
bomb. The radiological agent used in this test investigate the range of depths to which the
was the residue from the 30 November 1949 pellets penetrate the soil, to determine the
test (Field Test 276). No new contaminant feasibility of locating individual radiological
was used. The objective was to determine the warfare pellets by means of gamma survey
practicality of several proposed methods for meter or by means of beta probe, to
gross decontamination of areas (either area determine the feasibility of removing
wide or paths wide enough for the passage of individual pellets and the time required for

TABLE 2 RADIOLOGICAL WARFARE DECONTAMINATION AND CONSTRUCTION EVALUATION FIELD


TESTS CONDUCTED AT DUGWAY PROVING GROUND, UTAH, 1950 - 1952

Date of Field Test Test Designation Type of Field Test Source of Contaminants
August 1950 Field Test 291 gross decontamination residue from 30 November 1949 field test
study

26 July 1950 Field Test 311 construction point source of tantalum-182


31 August 1950 test
1 September 1950

4-10 June 1952 Field Test decontamination and residue from previous field test
DPG RW 5-52 land reclamation studies
Chapter 6—Radiological Warfare 67

this operation, to obtain data on the funding for the 1954 fiscal year had been extremely
performance of proposed land reclamation reduced. The planned budget of $4.33 million was
measures, and to evaluate waste collection reduced to $222,000.36 This substantial loss of funds
and disposal procedures.33 resulted in the Chemical Corps not going ahead with
the expansion it was proposing.

THE JOINT RADIOLOGICAL WARFARE STUDY


P ANEL REEVALUATION SUMMARY

The Noyes Panel, which presented its final The development of offensive weapons during
report on 20 November 1950, reconvened for a World War II was critical, and in the beginning
short time in April 1952 to discuss the status of the stages of the Manhattan Project the ability to
radiological warfare program. The group evaluated construct an atomic weapon was not a certainty.
the technical advances that had been made in the Radiological warfare provided the U.S. military
field of radiological warfare since the Joint Study forces with another possible option. The capability
Panel’s last meeting in 1950. The group found of delivering a radiological contaminant into the
there had been advancements in several categories: environment to deny an enemy control over
production of radiological warfare agents, specific terrain would have been a potentially
dissemination of radiological warfare agents, and potent addition to the U.S. weapons arsenal.
decontamination and defensive measures. There The need to explore adequately the potentialities
were no significant changes in the areas of new of radiological warfare and the fear that other nations
radiological warfare agent discovery, delivery, or might use this type of warfare motivated the research
biological effects. The panel decided that “no and development of the radiological warfare program.
controversial technical problems have developed The tests conducted at ORSL and Dugway Proving
since the last Noyes Panel report.”34 Ground were intended to determine the best methods
of radiological agent dispersal and damage capability.
According to the Advisory Committee on Human
THE C ANCELLATION OF THE OFFENSIVE Radiation Experiments:
RADIOLOGICAL WARFARE PROGRAM
“Whatever public health hazard the [radiologi-
cal warfare] tests at Dugway may have posed
The radiological warfare test program at Dugway
at the time, the radioactive decay of the tanta-
Proving Ground continued until 1952, when the lum caused the risks to dissipate over time.
Chemical Corps expressed a wish to substantially By 1960, no more than a few millicuries of tan-
expand the radiological warfare program. Increasingly talum remained, dispersed so widely that by
larger tests, planned for 1953 and following years, this time it posed no conceivable human or
would have needed vastly expanded facilities to environmental hazard.”37
maintain radioactive munitions.35
However, in 1953, the radiological warfare test
program was canceled. Several reasons contributed to N OTES
the program’s discontinuation. There were questions
relating to the actual need for a continuing radiological (To obtain copies of the following documents, see appendix 2.)
warfare program, and the expansion of the nuclear
1. Report by Col. James P. Cooney, Medical Corps,
weapons arsenal made radiological warfare less necessary
“General Indoctrination,” 24 February 1950, p. 1.
as an offensive measure. There were also budget cuts in
military spending, which were necessary at the 2. Defense Nuclear Agency 6032F, “Operation
conclusion of the Korean War. As of 10 June 1953, the CROSSROADS Report-1946,” United States Atmospheric
68 Chapter 6—Radiological Warfare

Nuclear Weapons Tests, Nuclear Test Personnel Review, 1 15. AEC, Radiological Warfare Program Status Report,
May 1984, p. 1. Sixth Meeting of Joint AEC-NME Panel on
Radiological Warfare, TID-397, 20 November 1950,
3. Ibid, p. 1. Conclusions, p. 6.

4. Memorandum, from Joseph G. Hamilton, M.D., to 16. Preliminary Summary of First RW Munition Test,
Col. K. D. Nichols, Subject: “Radioactive Warfare,” Dugway Proving Ground, 31 October 1949.
31 December 1946, p. 7.
17. Preliminary Summary of Second RW Munition
5. Ibid, p. 1 Test, Dugway Proving Ground, 13 December 1949.

6. Radiological Warfare Study Group, Second Report, 18. Army Chemical Corps, Planning and Evaluation
Military Application of Radioactive Materials, 17 June Branch, Test Division, Interim Report, “Report of Field
1948, p. 1; Advisory Committee on Human Radiation Test 287, Airburst Test of a Single 2000 Pound
Experiments, Final Report (Washington, D.C.: U.S. Radiological Bomb E59R1, Filled with Radioactive
Government Printing Office, October 1995), p. 519. Tantalum Particles;” “Report of Field Test 288, Drop
Test of a Single 2000 Pound Radiological Bomb E59R2,
7. Memorandum, to Military Liaison Committee, Filled with Radioactive Tantalum Particles” (Maryland:
Subject: “Panel to Investigate Safety of Civilian Army Chemical Center, 7 April 1952).
Populations from Tests of Radiological Warfare Agents,”
2 May 1949. 19. Ibid.

8. C. B. Marquand, Secretary, Test Safety Panel, Capt. S. 20. Army Chemical Corps, Planning and Evaluation
C. Hadwich, Chemical Center, Assistant Secretary, Test Branch, Test Division, Interim Report, “Report of Field
Safety Panel, “Meeting of the Test Safety Panel at Dugway Test 293, Static Test of Four Shaped-Charge Sections of
Proving Ground on 2 August 1949,” 22 August 1949, p. 3. Radiological Bomb, E59, Filled with Radioactive
Tantalum Particles” (Maryland: Army Chemical Center,
9. Ibid. 10 April 1952).

10. Letter, from Joseph G. Hamilton, M.D., to Dr. C. B. 21. Army Chemical Corps, Planning and Evaluation
Marquand, “Confirming Decisions Made by the Panel at the Branch, Test Division, Interim Report, “Report of Field
2 August 1949 Meeting,” 4 August 1949, pp. 1–2; Report of Test 289, Airburst Test of a Single Radiological Bomb,
the Test Safety Panel, appendix J, 15 September 1949, p. 3. E65, Filled with Radioactive Tantalum Particles”
(Maryland: Army Chemical Center, 7 April 1952).
11. Report of the Test Safety Panel, appendix J,
15 September 1949, p. 4. 22. Army Chemical Corps, Planning and Evaluation
Branch, Test Division, Interim Report, “Report of Field
12. Memorandum, from Maj. Gen. Alden H. Waitt, Test 290, Airburst Test of a Single 2000 Pound
Chief, Chemical Corps, to Director, Research and Radiological Bomb, E65R2, Filled with Radioactive
Development Division War Department General Staff, Tantalum Particles” (Maryland: Army Chemical Center,
7 February 1947, p. 1 of enclosure. 7 April 1952).

13. DOE, Assistant Secretary for Environment, Safety, 23. Army Chemical Corps, Planning and Evaluation
and Health, Human Radiation Experiments: The Branch, Test Division, Interim Report, “Interim Report
Department of Energy Roadmap to the Story and the Records of Field Test 292, Static Tests of Experimental
(Oak Ridge, Tenn.: Office of Scientific and Technical Radiological Dust Generators, E66R2 and E66R3, Filled
Information, February, 1995), p. 216. Radioactive Tantalum Oxide, Radioactive Tantalum
Chloride, and Radioactive Agent RA” (Maryland:
14. Ibid. Army Chemical Center, 29 September 1952).
Chapter 6—Radiological Warfare 69

24. Army Chemical Corps, Planning and Evaluation 32. Army Chemical Corps, Planning and Evaluation
Branch, Test Division, Interim Report, “Report of Field Branch, Test Division, Interim Report, “Report of Field
Test 619, Static Test of Four Full-Diameter Sectional Test 311, Test of the Effect of Various Types of
Munitions, E65 Type, Filled with Radioactive Tantalum Construction on the Intensity Field Produced by a
Dust Pellets” (Maryland: Army Chemical Center, Radioactive Tantalum Source” (Maryland: Army
19 May 1952). Chemical Center, 29 September 1952).

25. Army Chemical Corps, Planning and Evaluation 33. Technical Report, “Field Test DPGR 109 RW 5-52,
Branch, Test Division, Interim Report, “Report of Field Land Decontamination Test” (Dugway Proving Ground,
Test 620, Airburst Test of Nine Spherical Radiological 3 June 1953).
Munitions, E78R2 and E78R3, Aerial Pellet
Disseminators Filled with a Radioactive Agent, and 34. Memorandum, from Maj. Thomas A. Gibson, Jr.,
Bursting at Varying Altitudes” (Maryland: Army Chemical Corps, Radiological Branch, to Chief of Staff,
Chemical Center, 10 October 1952). AFSWP, Regarding “A Technical Study Group to
Review the Technical Aspects of Radiological Warfare,”
26. Army Chemical Corps, Planning and Evaluation 23 April 1952, p. 3.
Branch, Test Division, Interim Report, “Report of Field
Tests 623 and 624, Airburst Test of Two, 1000 Pound 35. Memorandum, from Brig. Gen. William M. Creasy,
Radiological Bombs, E-83, Filled with Compressed Commander, Chemical Corps Research and Engineering
Radioactive Tantalum Dust Pellets” (Maryland: Army Command, to Chief Chemical Officer, Department of
Chemical Center, 27 June 1952). the Army, Regarding Minimum Fund Requirements in
the AW Field, with Attached Budget Memo, 24 June
27. Ibid. 1953, p. 1.

28. C. Glenvil Whitacre, Army Chemical Corps, 36. Memorandum, from Brig. Gen. William M. Creasy,
Chemical and Radiological Laboratories, Interim Commander, Chemical Corps Research and Engineering
Report, “Report of Field Test DPG RW 1-52, Static Test Command, to Chief Chemical Officer, Department of
of Four Full-Diameter Sectional Munitions, E83 Type, the Army, Regarding Reduction of Funds in the AW
Filled with Radioactive Compressed Tantalum Dust Field, 15 June 1953, p. 1.
Pellets” (Maryland: Army Chemical Center, 2 July
1953); Technical Report, “Field Test DPGR 107 RW 1- 37. Advisory Committee on Human Radiation
52, Static Test of Sectional Munitions” (Dugway Experiments, Final Report (Washington, D.C.: U.S.
Proving Ground, 7 May 1953). Government Printing Office, October 1995), p. 537.

29. Technical Report, “Field Test DPGR 108 RW 2-52,


Test of Spherical Munitions” (Dugway Proving Ground,
15 May 1953).

30. Technical Report, “Field Test DPGR 120 RW 1-53,


Second Static Test of Sectional Munitions” (Dugway
Proving Ground, 18 September 1953).

31. Army Chemical Corps, Planning and Evaluation


Branch, Test Division, Interim Report, “Report of Field
Test 291, Gross Decontamination Studies on
Radioactive Tantalum Dispersed by a Single
Radiological Bomb” (Maryland: Army Chemical
Center, September 1952).
70
CHAPTER
HUMAN ASPECTS RESEARCH &
7 U.S. ATMOSPHERIC NUCLEAR
WEAPONS TESTING
I NTRODUCTION the sole nuclear power came to an end. In view of
this, the DoD realized it would be necessary to create
Since 1994, the Department of Defense (DoD) countermeasures for both personnel and equipment
has conducted an extensive search for records to conduct operations on a contaminated battlefield.
involving human use in ionizing radiation research First, the effects of atomic warfare on military
and testing. As of the date of this publication, no operations had to be identified.2 Effects included
documentation has been identified to indicate that contaminated fallout from the “mushroom cloud,”
human radiation experiments were part of the U.S. flashblindness or dazzle created by the fireball, and
atmospheric nuclear weapons testing program. The the psychological stress on personnel from a nuclear
Advisory Committee on Human Radiation detonation. Second, after the effects were identified,
Experiments (ACHRE) concluded in 1995 that, defensive or avoidance techniques had to be
“although there was a real possibility that human developed to minimize or eliminate the threat.
subject research had been conducted in conjunction The primary objective of the U.S. atmospheric
with the bomb tests, the tests were not themselves nuclear weapons test program was to develop and
experiments involving human subjects.”1 improve nuclear weapons.3 However, some of the tests
Human aspects research conducted in were conducted to evaluate nuclear weapons effects.
conjunction with atomic weapons tests was designed Such weapons tests offered an opportunity to
to study the effects atomic weapons would have on determine the effects on military operations and to
combat operations. For example, flashblindness develop and test equipment, operational doctrine,
studies, troop training and maneuvers, psychological and the tactics to be used by U.S. forces in a nuclear
testing, and decontamination studies were designed environment. Personnel participated in field exercises
with the goal of increasing the capabilities and which were conducted in conjunction with the
preparedness of military forces to conduct effective weapons tests.
military operations on a nuclear battlefield. Cloud
sampling and penetration were conducted to collect
radiological samples from nuclear mushroom clouds, H UMAN I NVOLVEMENT
to gather radiochemical data, and to identify the
potential risk to aircrews. This chapter describes this Development of Military Operations on a
research. Nuclear Battlefield

Approximately 210,000 personnel participated in


B ACKGROUND U.S. atmospheric nuclear weapons tests.4 Their
participation included observing the explosion, test
When the Soviet Union detonated an atomic operations, and tactical maneuvers on a simulated
bomb in 1949, the monopoly of the United States as battlefield following a nuclear detonation. Personnel
71
72 Chapter 7—Human Aspects Research & U.S. Atmospheric Nuclear Weapons Testing

TERMS/ACRONYMS USED IN THIS CHAPTER after detonation to test air


mobile operations around and
AEC Atomic Energy Commission [predecessor of the through a contaminated and
Department of Energy] cluttered battlefield. The
afterimage temporary image formation remaining on the retina results of these exercises were
from over stimulation used to refine and improve
dazzle to overpower the vision with very bright light military operations on a
nuclear battlefield.
DoD Department of Defense Decontamination procedures
fallout the descent to earth of radioactive particles, as after also were used and tested.
a nuclear explosion; the particles themselves Some service members
flashblindness describes both dazzle (a condition where extremely were administered psychological
bright light temporarily impairs vision) and tests to determine the
afterimage (temporary image formation remaining effectiveness of briefings about
on the retina from over stimulation) the atomic bomb. The purpose
of such testing was to determine
gamma ray an electromagnetic radiation of great penetrating
power, emitted by the nucleus of a radioactive if troops had been given
substance adequate information that they
could understand and use in
ground zero place of detonation performing safely on a nuclear
ionizing radiation (see appendix 4) battlefield.5
mushroom cloud the cloud produced by an atomic explosion, forming
a unique mushroom shape
Visual Effects
night vision vision that has adapted to low light levels

NTPR Nuclear Test Personnel Review The Armed Services


were confronted with the
rad (radiation absorbed dose) a dosage of absorbed
problem of temporary loss of
radiation equal to the absorption of 100 ergs of
energy per gram of material
vision as a result of exposure to
visible light emitted by a
nuclear detonation. The term
“flashblindness” was used to
from all the services, primarily the Army, participated describe both dazzle (a condition in which extremely
in a series of field maneuvers called “Desert Rock.” bright light temporarily impairs vision) and
The purposes of these exercises included conducting afterimage formation from retinal stimulation.6 The
field maneuvers, evaluating the effects of a nuclear danger to the eye from an atomic detonation lies in
detonation on field fortifications and equipment, the increased light the eye receives, which can be as
measuring the ability to estimate target damage, much as 50 times the light a pupil constricted by
observing psychological responses to nuclear daylight admits. There is an even greater effect on
detonations, and radiological safety training. During pupils that are already dilated, such as when adapted
these exercises, service members first received to night vision. There was also concern that the
training on nuclear weapons and their effects and elimination of night-adapted vision caused by intense
how to survive and operate on a nuclear battlefield. illumination from a nuclear detonation at night could
After the blast, some troops executed maneuvers severely distort peripheral vision in critical situations.
toward ground zero from trenches. Others were The flashblindness project was conducted
airlifted by helicopter to the vicinity of ground zero during Operations BUSTER-JANGLE,
Chapter 7—Human Aspects Research & U.S. Atmospheric Nuclear Weapons Testing 73

Intensity of the flash of the detonation of an atomic bomb at night. The intensity of the flash could
cause temporary blindness to those unprotected.

TUMBLER-SNAPPER, UPSHOT-KNOTHOLE, flash of an atomic bomb for a period of time equal to


PLUMBBOB, HARDTACK II, and DOMINIC I. the blink reflex. Red filters were found to curb the
The flashblindness project examined the ability of high short-wave content of the early part of
filters to decrease the effects of flashblindness on detonation flash and thus aid recognition of red-
ground troops and aircrews. lighted instruments. It was concluded that aircrews
Three types of visual tasks were considered for would benefit from using red filters in the event of
the flashblindness program: (1) reading red-lighted atomic flashes within a few miles at night.8
instruments in ships, aircraft, and vehicles; (2) acuity Flashblindness researchers concluded that the
of central vision; and (3) peripheral vision at low temporary loss of vision from dazzle did not cause
light levels. Aircrews increasingly relied on central permanent damage to the eyes.9 With proper training,
vision in performing operational tasks, whereas coping with temporary vision loss was found to be a
ground soldiers relied on peripheral vision to detect surmountable obstacle. Tests showed that permanent
form and movement in night combat tasks.7 eye damage was possible when the detonation was
Researchers designed studies to estimate the viewed directly; when the detonation was viewed
usefulness of a specific filter combination for dazzle indirectly, the possibility of permanent damage was
protection. Typically, service members whose eyes minimized.10 In viewing a detonation either directly
had been adapted to the dark looked at the initial or indirectly, vision was temporarily impaired. Field
74 Chapter 7—Human Aspects Research & U.S. Atmospheric Nuclear Weapons Testing

“Box” filter being removed from a B-17 “drone” cloud sampling aircraft

and laboratory flashblindness experiments with dose rates. The Air Force needed the ability to
human subjects continued into the 1960s and 1970s estimate the impact of contamination within a cloud
and led to the development of equipment for layer to judge the hazards of flying into a mushroom
improved eye protection. cloud.12 This information was critical to the Air Force
for two reasons: (1) to determine the hazards to pilots
who may have to fly through mushroom clouds either
Nuclear Cloud Penetration Studies during a cloud sampling mission or during a nuclear
war and (2) to determine what decontamination
The Air Force conducted mushroom cloud procedures would be required if the aircraft became
sampling flights after nuclear weapons tests for radioactive after passing through these clouds. These
several reasons. One was to obtain samples that could studies would also help in identifying requirements
be used by the weapons designers to analyze the for additional protective equipment for personnel and
performance and efficiency of the weapon’s design. machinery.
Obtaining samples provided diagnostic information The Air Force initially conducted unmanned
to the weapons design laboratories. A second reason experimental mushroom cloud penetration missions.
was to collect samples from mushroom clouds of However, manned aircraft soon replaced the
nuclear detonations performed by other nations. The cumbersome and unreliable remote-controlled
purpose of this information was of intelligence value aircraft, known as drones, which did not provide the
in determining the nature of other countries’ nuclear quality of mushroom cloud samples required. In these
weapons development programs.11 A third reason, cloud penetration studies, some air crew flew through
which is discussed here, was to fly through a mushroom clouds to determine if there was a
mushroom cloud to measure the radiation dose and radiation threat; others flew in or around the clouds
Chapter 7—Human Aspects Research & U.S. Atmospheric Nuclear Weapons Testing 75

Cloud sampling filter being placed on a cart after being removed from a F-84 sampling aircraft

to gather additional data from the radioactive clouds. within the body was nearly the same as the dose on
The radiation doses that aircrews received during the skin surface and indicated that aircraft did not
passage through and around the cloud and conditions have to be specially modified to filter out airborne
of the flight inside the cloud and on the return flight particles that could be inhaled by aircrews.14
were pertinent in the safety planning for aircrews and The second objective of the studies was to
aircraft.13 determine the radiological contamination the aircraft
One objective of the studies involved measuring might acquire from flying through or around the
the radiation dose either from inhaling or swallowing mushroom cloud and the extent of the radiation
radioactive particles while flying through a exposure from this contamination to the ground
mushroom cloud. External radiation dose rates crews who serviced these aircraft. The studies
experienced in mushroom clouds were often demonstrated that the major risk to ground crews
dangerously high, sometimes 1,800 rads per hour. came from residual radiation deposited on both
However, because aircraft did not linger in the cloud, external aircraft surfaces and internal aircraft parts.
the total dose was much less, but there was concern The major deposition point for such residual
whether internal doses paralleled these external radiation was in the engines, which drew in the
readings. These cloud penetration tests were able to radioactive fallout as the aircraft traveled through the
provide distinction between internal and external mushroom cloud.15 As a result of this and other
doses received during a mushroom cloud penetration studies, decontaminating aircraft after passage
flight. Test data showed that the radiation dose through a mushroom cloud was deemed necessary to
76 Chapter 7—Human Aspects Research & U.S. Atmospheric Nuclear Weapons Testing

Air Force F-84 being directed to a holding area to await decontamination. The aircraft had been on a
cloud sampling mission. Upon landing, the aircraft was surveyed for radioactivity and found to exceed
acceptable levels.

remove residual radiation. Aircraft returning from absorbed by their bodies, but many others flew in or
missions involving mushroom cloud penetration were around atomic clouds to gather data on radiation in
required to be checked for radioactivity to determine the clouds. The Department of Defense generally did
if decontamination was necessary. not distinguish such research from otherwise similar
The historical narrative “History of Air Force activities, treating both as part of the duties of
Atomic Cloud Sampling” provides an in-depth military personnel. The experience of atomic
overview of the complete cloud sampling operation.16 veterans illustrates well the difficulty in locating the
boundary between research involving human subjects
and other activities conducted in occupational
E PILOGUE settings that routinely involve exposure to hazards.”17

The ACHRE Final Report stated that ACHRE:


“reviewed the historical record to determine if human FOR MORE I NFORMATION
experiments had taken place in connection with
these tests. We found that somewhere in the range of In 1978, the DoD established the Nuclear Test
2,000 to 3,000 military personnel at the tests did Personnel Review (NTPR) program to serve as a
serve as the subjects of research in connection with source of public information for personnel
the tests. In most cases, these research subjects were participating in these tests. The NTPR program is
engaged in activities similar to those engaged in by responsible for identifying DoD personnel who
many other service personnel who were not research participated in U.S. atmospheric nuclear tests and for
subjects. For example, some air crew flew through determining their radiation doses. This program
atomic clouds in experiments to measure radiation provides participants with confirmation of their
Chapter 7—Human Aspects Research & U.S. Atmospheric Nuclear Weapons Testing 77

Air Force F-84 undergoing decontamination after flying through an atomic mushroom cloud

participation, their associated radiation dose, and the 4. DNA, NTPR Program, 14 January 1994.
availability of health care and compensation
programs. Contact the NTPR program at the Defense 5. Peter A. Bordes et al., “Desert Rock I: A
Special Weapons Agency, Attn: ESN/NTPR, 6801 Psychological Study of Troop Reactions to an Atomic
Explosion [HumRRO-TR-1],” February 1953.
Telegraph Road, Alexandria, VA 22310-3398, or by
calling 1-800-462-3683. 6. OPERATION HARDTACK, “Project 4.3, Effect of
Light from Very-Low-Yield Nuclear Detonations on Vision
(Dazzle) of Combat Personnel,” April – October 1958,
N OTES Headquarters Field Command, Defense Atomic Support
Agency, p. 9.
(To obtain copies of the following documents, see appendix 2.)
7. Victor A. Byrnes et al., “Ocular Effects of Thermal
1. Advisory Committee on Human Radiation Radiation from Atomic Detonations — Flashblindness
Experiments, Final Report (Washington, D.C.: U.S. and Chorioretinal Burns, Project 4.5,” School of Aviation
Government Printing Office, Oct. 1995), p. 455. Medicine, 30 November 1955, p. 3.

2. JPMAAW, “Program Guidance,” 20 September 1951. 8. OPERATION UPSHOT-KNOTHOLE, Summary


Report of the Technical Director, March–June 1955,
3. “United States Nuclear Tests, July 1945 Through Headquarters Field Command, Armed Forces Special
September 1992,” DOE/NV-209 (Rev. 14), December Weapons Project, p. 141.
1994, pp. vii – viii. Note: The conclusion stated here was
drawn from the definitions of “weapons effects” and 9. OPERATION HARDTACK, “Project 4.3, Effect of
“weapons related” tests and the “totals by purpose” Light from Very-Low-Yield Nuclear Detonations on Vision
information on these pages. (Dazzle) of Combat Personnel,” April –October 1958,
78 Chapter 7—Human Aspects Research & U.S. Atmospheric Nuclear Weapons Testing

Headquarters Field Command, Defense Atomic Support


Agency, p. 28.

10. Ibid, p. 23.

11. Memorandum, from General Dwight D. Eisenhower,


Army Chief of Staff, to Commanding General, AAF,
Subject: “Long Range Detection of Atomic Explosions,”
16 September 1947.

12. History of Air Force Atomic Cloud Sampling,


Narrative, January 1963, AFSC Historical Publications
Series 61-142-1.

13. OPERATION REDWING, “Project 2.66a, Early


Cloud Penetrations,” Headquarters Field Command,
Defense Atomic Support Agency, 24 February 1960,
Chapter 1, Introduction.

14. Air Force System Command, “History of Air Force


Atomic Cloud Sampling,” Historical Publication 61-142-1,
SWEH-2-0034, January 1963.

15. Ibid.

16. Ibid.

17. Advisory Committee on Human Radiation


Experiments, Final Report, pp. 455–456.
CHAPTER
FOOD IRRADIATION
8
I NTRODUCTION TO IRRADIATED F OOD S TUDIES assigned the Quartermaster Corps, Department of the
Army, the task of investigating the technical aspects
Food irradiation studies, sponsored by the Army of the radiological sterilization and preservation of
Quartermaster General, were part of the “Atoms-for- foods.3 This task was conducted in close coordination
Peace” initiative of the mid-1950s and continued with the AEC, which supplied the sterilization
until 1980. The Atoms-for-Peace program was testing reactor and radiation source used for
initiated by President Eisenhower in 1956 to generate irradiating foods. Many other governmental
research and development on constructive, peaceful organizations became involved in food irradiation
uses of atomic energy.1 This program, along with the studies during the following years. The Army also
War-on-Hunger program, was strongly supported by sponsored laboratory studies of irradiated foods at
Congress and the Department of Defense (DoD). approximately eighty universities and industrial
The purposes of irradiating food were to sterilize organizations throughout the country during the
foods intended for use as field rations, extend shelf 1950s.4
life under nonrefrigerated conditions, and make food The logistical requirements to keep an Army in
preparation easier in combat situations while keeping combat situations well fed for prolonged periods
the Army well nourished. Human testing of irradiated necessitated more efficient food storage and
food began in 1956 after several years of animal preparation procedures. At the time, field rations
testing revealed no health risks. These tests were not required refrigeration, spoiled quickly, were
considered human-use tests; no food used in these cumbersome to transport, and sometimes required a
studies became radioactive as a result of the lot of water or cooking time for preparation. Food
irradiation.2 These food irradiation studies were irradiation was seen as a means to address these
conducted only to gauge the soldiers’ reactions to the concerns. The sterilization of grain and grain
sensory characteristics of the irradiated foods. Today, products with heat and the control of parasites in
the use of food irradiation to eliminate grain, although possible, were limited in their
microorganisms and to extend shelf life is a common applicability due to how the foods were stored. The
practice in several fields of food processing and DoD sponsored research in food irradiation to
packaging in commercial and military food determine the feasibility of using ionizing radiation
preparation. (such as gamma rays and electrons) instead of heat to
kill or inactivate micro-organisms that cause food
spoilage. Ultimately, the benefits of the irradiation
B ACKGROUND process would include, “a reduction in refrigeration
requirements, reduced food losses, improved control
The concept of food irradiation was initially of certain food-borne diseases, and a wider
developed by the Atomic Energy Commission (AEC) availability of fresh foods under field conditions.”5
immediately following World War II. In 1952, the Laboratory tests of irradiated foods were
DoD expressed interest in a food irradiation program. conducted on rats, dogs, and monkeys at various
In February 1954, the National Research universities and industrial organizations. After
Council’s Subcommittee on Radiological Sterilization extensive animal tests did not reveal any harmful
79
80 Chapter 8—Food Irradiation

TERMS/ACRONYMS USED IN THIS CHAPTER The first Army-sponsored


human subject study of
AEC Atomic Energy Commission [predecessor to the irradiated food took place in
Department of Energy 1956 at the Army Medical
cobalt-60 a radioactive isotope used in the treatment of cancer Research and Nutrition
Laboratory, Fitzsimons Army
DoD Department of Defense
Hospital, in Denver, Colorado.
FDA Food and Drug Administration The participants were
gamma radiation electromagnetic, rather than charged particle, Mennonite volunteers:
radiation; highly penetrating eighteen conscientious
objectors, between eighteen
ionizing radiation see appendix 4
and twenty-two years old, who
irradiate to expose to or treat by exposing to x-rays, ultraviolet were fulfilling their obligation
rays, radium, or some other form of radiant energy to the Government by serving
pasteurization a method of destroying disease-producing bacteria in the Armed Forces as test
by heating the liquid to a prescribed temperature for volunteers for an eighteen-
a specified period of time month period. Before their
sterilization to free from living microorganisms, as by subjecting participation, the men were
to great heat or chemical action given a thorough briefing that
provided a history of the
TECOM Army Test and Evaluation Command
program and an explanation
World War II 1939-1945, fought between the Allies (Great Britain, that the food was not
France, the Soviet Union, Canada, and the United radioactive and that previous
States as well as other nations) and the Axis animal toxicity testing had
(Germany, Italy, Japan and other countries) been negative. Before
participating, they filled out
informed consent forms that
included participation in two-year liability insurance
effects, the protocol for human taste testing was
policies from the University of Colorado. Complete
established in 1954. By 1956, more than 100 foods
physical examinations were administered just before,
had been laboratory tested and were approved for
during, and at three, six, and twelve months after the
further human subject testing using both civilian and
studies were completed.8
military volunteer personnel.6
Seven separate studies were conducted at
Fitzsimons Army Hospital, each lasting
HUMAN TESTING OF IRRADIATED FOODS approximately thirty days. During each test period,
the participants were divided into two groups of equal
Human volunteer tests were conducted to size. One group received meals that included
determine the sensory characteristics—taste, texture, irradiated food, while the other group ate meals with
and appeal—of the irradiated meats, fruits, and no irradiated food. After approximately fifteen days,
vegetables. The Army Test and Evaluation Command the test administrators switched the group that was
(TECOM) administered the tests through the fed untreated meals with the group that ate irradiated
Quartermaster Corps at the U.S. Army Natick food, so each group ate equal amounts of irradiated
Research, Development, and Engineering Center in food. To maintain the control population and get a
Natick, Massachusetts. Much of the human taste more accurate indication of the acceptance of the
testing was also done for psychological reasons to irradiated foods, the men were not told which foods
calm public fears of irradiated foods. 7 they were eating.9 A period of several months elapsed
Chapter 8—Food Irradiation 81

between the studies to prevent accumulation of tests were designed as new techniques of irradiation
possible toxic effects. This testing procedure was used were developed to be conducted on foods that had
in most of the subsequent irradiated food studies. not been acceptable to the test subjects in previous
The first four studies tested foods that had been studies. However, these further studies were not well
kept in a frozen state until they were prepared and documented, and the current data on them are
consisted of 35 percent, 60 percent, 80 percent, limited.
and 100 percent irradiated foods, progressively.10 Letterman Army Medical Center at the Presidio
Eighteen men participated in these tests, which Army Base in San Francisco, California, was the site
began in summer 1956 and consisted of taste- of several initial and follow-up food irradiation taste
testing forty-two food items. The fifth study, tests. The testing techniques and procedures used at
conducted in spring 1957, specifically tested the Fitzsimons Army Medical Nutrition Laboratory were
acceptability of irradiated pork that had been also used at Letterman. The currently available
stored at room temperature for one year. The sixth information on the testing conducted at Letterman
and seventh studies, completed in November 1957 Army Medical Center does not contain data on the
and March 1958, investigated eighteen foods that
had been stored
at room
temperature for
three months.
Thirteen men
participated in
these two tests.

FOLLOW-U P
S TUDIES

Several
follow-up studies
were conducted
at Fitzsimons
Army Hospital.
A four-month
duration test
based on a diet of
100 percent
irradiated food
was planned to
begin on 1 March
1959. The
volunteers for
these tests were
Mennonite Potatoes being irradiated during a food preservation study. This process did not
conscientious cause the food itself to become radioactive. Rather, it destroyed organisms which
objectors.11 would have caused spoilage of the food. This process lengthened the storage life of
These follow-up these foods.
82 Chapter 8—Food Irradiation

large-scale food irradiation


studies were conducted at
Fort Lee, Virginia, Fort
Lewis, Washington, and
Marine Corps installations
on the island of Okinawa
from 1958 through the mid-
1970s. Personnel involved
in these studies were
volunteer enlisted men at
each site.
The irradiated food
taste tests conducted at Fort
Lee began in February 1958.
Approximately two weeks
before these tests began, a
series of lectures on the
subject of radiation
preservation was presented
to approximately 2,000
enlisted men, representing
most of the 543rd
Quartermaster Group, the
9111th Detachment 2, and
the Quartermaster School.
These lectures were
designed to acquaint as
many people as possible
with the general historical
background and progress in
the use of radiation to
preserve food. The men
were told that the irradiated
food program was not
Food test samples depicting effectiveness of irradiation as a classified and that all who
preservation process. Food on the right had been irradiated, whereas participated would not only
the food on the left had not. Both samples had been left unprotected be allowed but encouraged
for the same period of time. Food on the left shows signs of spoilage, to tell their friends and
whereas the food on the right does not. Food items are sausage, relatives that they
bread, cheese, and beans. participated in the test.
Following each lecture,
foods that were tested, the testing methods used, or personnel were surveyed to determine whether they
the number of participants. would be willing to participate in the program on a
After the initial success of these small-scale volunteer basis.12
human subject irradiated food studies, the Army The Army’s Office of the Surgeon General
increased the size and scope of the program. Many handled the medical supervision of the participants
Chapter 8—Food Irradiation 83

and laboratory preparation of the irradiated food. All STERILIZATION VERSUS PASTEURIZATION
study volunteers at Fort Lee were given physical
examinations two weeks before ingesting irradiated Sterilization
food. From the personnel who volunteered for the Sterilization is primarily used for long-term
first study and successfully passed the physical preservation of meats and meat by-products in an
examinations, a group of 240 men was selected to uncooked or unfrozen state. These foods require a
participate. Only 139 volunteers from this group high dose of radiation to kill, or inactivate, the
actually ate irradiated food; the remaining men microorganisms that cause spoilage. The
preservation of foods by sterilization and the foods
served as the control population. Records indicate
irradiated by this method are currently being
that these volunteers were served a meal that researched for approval by the Food and Drug
included irradiated bacon and pork along with non- Administration.
irradiated foods on 25 April 1958.13
The second series of tests, consisting of two Pasteurization
three-day studies, tested the sensory reactions to six Pasteurization is used for highly perishable
irradiated foods. The first of these studies took place food, primarily fruits and vegetables, that require a
on 3, 6, and 10 November 1958 and had 139 low dose of radiation to extend shelf-life and kill, or
volunteers; the second study on 1, 4, and 8 December inactivate, the microorganisms that cause
1958 had 87 volunteers. As with the first study, after spoilage. The pasteurization method leaves the
food nearly indistinguishable from non-irradiated
consuming each meal, the participants were asked to
food. The irradiation pasteurization procedure is
fill out nine-point scaled questionnaires on the commonly used on fruits and vegetables
sensory characteristics of the food, including the commercially available today.
texture, taste, and palatability.14
Test procedures called for follow-up physical
the continuation of the food irradiation program was
examinations to be given to participants immediately,
directed by the U.S. Army Natick Research,
after six weeks, and three months after eating the
Development, and Engineering Center, in Natick,
irradiated food. However, the three month post-
Massachusetts, where several follow-up taste tests
irradiation tests were deemed unnecessary because no
were conducted.
ill effects from the irradiated food ingestion were
Most of the additional testing was done to get a
discovered during the previous physicals. In January
more accurate indication of the potential broad
1959, after the second phase of testing at Fort Lee
acceptance and use of irradiated foods. It was
was complete, a report on the medical aspects of the
eventually determined that the radiation
program noted, “[t]o date, of the 598 volunteers
pasteurization process, which used doses that would
examined, there has been no evidence from our
delay spoilage, when used in conjunction with
examinations to suggest any effects attributable to
refrigeration17 did not affect the sensory qualities of
consumed irradiated food.”15
foods as much as the radiation sterilization procedure.
Similar testing procedures were used for all the
This was found to be the case first with fruits and
follow-up taste tests of irradiated foods that were
vegetables and was eventually applied to all irradiated
administered at Fort Lee, Fort Lewis, and the Marine
foods. However, because the DoD’s intention with
installations on Okinawa through the mid-1970s.
the food irradiation program was to prolong the shelf
Several other food irradiation taste tests were
life of meats and high-protein foods, the DoD
conducted at many other DoD facilities around the
continued to research and improve on the radiation
country, but these generally involved fewer troops
sterilization process. The development of new and
and were shorter in duration. In 1960, the Food and
more efficient irradiation techniques (e.g., replacing
Drug Administration (FDA) granted approval for the
gamma with electron radiation) also warranted
use of a broad class of irradiated foods for general
additional testing of irradiated foods. The
consumption by Army troops.16 The administration of
development of portable radiation sources was
84 Chapter 8—Food Irradiation

important because the foods could be irradiated close 3. Draft Letter, to Lewis L. Strauss, Chairman, Atomic
to their source. Before this, most of the food was Energy Commission, from Robert LeBaron, Chairman,
frozen, thawed just before irradiation, and then Military Liaison Committee, 10 February 1954, p. 1.
refrozen for shipping, which added to the
development of undesirable textures and tastes.18 The 4. Interdepartmental Committee on Radiation
Preservation of Food, Draft Second Report, p. 11 A.
study administrators at Natick eventually discovered
that if the foods were kept very cold (at -40o C) 5. Draft Press Release, “Army Troops to Test Palatability
during the sterilization process, the undesirable of Foods Preserved by Irradiation,” 7 April 1958, p. 3.
effects of the radiation treatment were virtually
eliminated. The Army also attempted to keep up 6. Interdepartmental Committee on Radiation
with the dietary guideline changes. As these needs Preservation of Food, Draft Second Report, pp. 16–18.
changed over the years, food irradiation studies were
continued for sterilization and pasteurization purposes 7. Ad Hoc Working Group, A National Civilian
and to extend shelf life. Radiation Processed Foods Program, p. 15.

8. Memorandum, to The Quartermaster General of the


Army, from Brig. Gen. Joseph McNinch, Special Assistant
SUMMARY for Research & Development Affairs, Office of the Army
Surgeon General, 2 October 1959, pp. 2–3.
The food irradiation program started by the Army
in the 1950s was administered with no reported health 9. Capt. Virginia E. McGary et al., Acceptability of
effects to the participants. Many people and ideas were Irradiated Food Consumed by Humans (Fitzsimons Army
involved in the effort to increase the efficiency of the Hospital, Colorado: U.S. Army Medical Nutrition
Army in the 1950s and 1960s. The food irradiation Laboratory, 15 March 1957), p. 1.
program was an integral part of this effort. Taste-test
10. Research Division, Office of the Chief of Research &
studies similar to those of the past have continued into
Development, Office of the Army Chief of Staff, “Status of
the present on foods produced with new packaging and the U.S. Army Radiation Preservation of Food Program,”
preservation techniques. To a large extent, the food July 1957, p. 2.
irradiation programs conducted at Fitzsimons Army
Hospital, Letterman Army Medical Center, Fort Lee, 11. Interdepartmental Committee on Radiation
Fort Lewis, and the Marine Corps installations on Preservation of Food, Draft Second Report, p. 18.
Okinawa were in the forefront of the effort to improve
quality and shelf life of food and, in turn, the quality of 12. Summary of Irradiated Food Studies conducted by the
food available for military personnel. Office of the Quartermaster General, 1958, p. 1, and
Enclosure 1, Troop Orientation, p. 2.

13. Capt. C. D. Moore, USA, Human Consumption of


N OTES Irradiated Food–Medical Aspects (Fort Lee, Va.:
Quartermaster Research and Engineering Command,
(To obtain copies of these documents, see appendix 2.) 22 January 1959), p. 1.

1. Ad Hoc Working Group of the Interdepartmental 14. Interdepartmental Committee on Radiation


Committee on Radiation Preservation of Foods, A Preservation of Food, Draft Second Report, p. 19.
National Civilian Radiation Processed Foods Program,
January 1960, pp. 16, 17; Budget message of President 15. Capt. C. D. Moore, Human Consumption of
Dwight D. Eisenhower to the Congress of the United Irradiated Food, p. 2.
States, January 1956.
16. Ad Hoc Working Group, A National Civilian
2. Ibid, p. 11 Radiation Processed Foods Program, p. 15.
Chapter 8—Food Irradiation 85

17. Interdepartmental Committee on Radiation


Preservation of Food, Draft Second Report, p. 13.

18. Ad Hoc Working Group, A National Civilian


Radiation Processed Foods Program, p. 21.

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